Technical Writer Sparks GroupTechnical WriterWashington, DC$40–$45 / hourp>Download the Sparks Group mobile app from Apple App Store or Google Play.. We offer several comprehensive benefits package including health and life insurance, paid and unpaid time off, and retirement and savings plans to qualifying employees..
Human Resources Manager Shred-Tech Asia Co., Ltd.Human Resources ManagerSriracha, CHOli>Ensure LRN is updated with new employee information for new hires, delete terminated employees, make sure all employees are compliant with training requirements by due date and train employees in a classroom setting for those that do not have email addresses. Full spectrum of Payroll management function such as collect & checking data, payroll processing, payment and summary report (Month-End, Year-End, Tax, Social Security Fund, etc.).
NewAssociate Attorney - National Security & Global Trade - Multi Office Gables Search GroupAssociate Attorney - National Security & Global Trade - Multi OfficeWashington, DC$260,000–$310,000 / yeardiv>Regulatory & Government Affairs Practice Group Location: Washington, DC preferredOther Locations Available – full list at the bottom of this description.. Interested candidates should submit a cover letter indicating their preferred office location, resume, and law school transcript for consideration.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRockville, MD$190,800–$300,300 / yearp>Required Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Strategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsDCYou will also partner with teams across Google and Alphabet's Public Policy, Compliance, Legal, Engineering, Finance and product areas to support the handling of some of the most important issues for the company today. In this role, you will work closely with members of Regulatory Affairs and act as the central operations support for the department"s role in the broader regulatory lifecycle.
CLINICAL DEVELOPMENT & REGULATORY AFFAIRS ASSOCIATE (ENTRY LEVEL) SciLucent LLCCLINICAL DEVELOPMENT & REGULATORY AFFAIRS ASSOCIATE (ENTRY LEVEL)Herndon, VARemote$50,000–$80,000 / yearp>The ideal candidate will have the following: • Bachelor's degree, in a relevant scientific discipline (e.g., biology, chemistry, biochemistry, clinical research, etc.) or equivalent relevant scientific/regulatory/quality experience, is required. We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.
Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) BroadridgeDirector, Government & Regulatory Affairs (Hybrid - Washington D.C.,)District of ColumbiaReporting to the Head of Government Affairs, this individual will play a critical role in advancing Broadridge's policy priorities by building and maintaining relationships with key federal officials, monitoring legislative and regulatory developments, and positioning Broadridge as a trusted resource among policymakers and industry stakeholders. The ideal candidate brings deep knowledge of the financial services regulatory landscape, a strong network on Capitol Hill and within federal agencies, and the ability to translate complex regulatory issues into clear, compelling narratives for a variety of audiences.
Principal Associate, Chief of Staff - Regulatory Affairs Capital One Financial CorpPrincipal Associate, Chief of Staff - Regulatory AffairsMcLean, VA$131,300–$149,800 / yearGEA teams include Regulatory Affairs, Risk, Innovation, Strategy and Enablement (RISE), Community Impact and Investment (CII), Community Finance, CRA Strategy and Program Management, Global Policy Affairs Group (GPAG), and Global Enterprise Communications (GEC). This associate will provide support to the Regulatory Affairs tower within GEA by executing, collaborating on and leading (as appropriate) substantive and significant projects and ongoing activities related to project delivery, team enablement and providing associates with a rewarding experience.
Director, Government & Regulatory Affairs (Hybrid - Washington D.C.,) Broadridge Financial Solutions IncDirector, Government & Regulatory Affairs (Hybrid - Washington D.C.,)DC$180,000–$190,000 / yearReporting to the Head of Government Affairs, this individual will play a critical role in advancing Broadridge's policy priorities by building and maintaining relationships with key federal officials, monitoring legislative and regulatory developments, and positioning Broadridge as a trusted resource among policymakers and industry stakeholders. The ideal candidate brings deep knowledge of the financial services regulatory landscape, a strong network on Capitol Hill and within federal agencies, and the ability to translate complex regulatory issues into clear, compelling narratives for a variety of audiences.
NewAssociate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyRockville, MD$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
Regulatory Affairs Scientist (Devices) U.S. Department of DefenseRegulatory Affairs Scientist (Devices)Fort Detrick, MD$121,785–$187,093 / yearFOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. In addition to meeting the basic requirement above, to qualify for this position you must also meet the qualification requirements listed below: Specialized Experience: One year of specialized experience which includes: Experience interacting with varied groups and types of internal and external stakeholders to provide regulatory support across Food and Drug Administration (FDA) regulated research and development efforts.
Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcSenior Director, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MD$218,058–$327,087 / yearp>Accountabilities: Global Regulatory Leadership: Own the end-to-end global regulatory strategy for a high-complexity cell and gene therapy program, from current stage through BLA submission, ensuring an efficient route to approval with competitive labeling aligned to product attributes and patient, market and business needs. Cross-Functional Product Leadership: Represent Regulatory Affairs on Global Product Teams, shaping development and commercialization plans, contributing to governance presentations and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.
Satellite Policy Associate Starlink Regulatory Affairs Space Exploration Technologies CorpSatellite Policy Associate Starlink Regulatory AffairsDC$150,000–$215,000 / yearp>RESPONSIBILITIES: • Assist with developing and advocating for broadband and spectrum policies that will further SpaceX's business objectives and Starlink's success domestically and internationally • Draft pleadings, letters, and other advocacy pieces to promote SpaceX's policy positions • Contribute to company satellite spectrum policy and outreach activities with government officials at all levels • Represent and promote the company positions before the FCC, the NTIA, and other Federal agencies, regulators, legislatures, and regional organizations • Direct regulatory practice to secure necessary U.S. licenses, regulatory compliance, and customer support for all SpaceX spacecraft, earth stations, and services for the Starlink program • Develop and administer regulatory licensing application preparation, pursuit, and compliance requirements for system and service licensing • Provide strategic regulatory advice and advocacy support to business development efforts • Advocate to optimize prospective satellite and telecoms regulatory frameworks and policy environments in alignment with SpaceX business objectives. PREferred SKILLS AND EXPERIENCE: • Bachelor's or master's degree in an engineering, math, chemistry, or physics discipline • Understanding of broadband policy • Understanding of spectrum use and policies • Knowledge of radiofrequency spectrum technology • Knowledge of telecommunications business and regulatory issues outside of the U.S. • Experience working with the Federal Communications Commission and other federal agencies • Knowledge of key commercial and government players in the telecommunications/broadband industry • Experience at a well-regarded law firm • Experience as an in-house lawyer ideally within the tech industry • Diligent and proactive, you have demonstrated excellent legal and business judgment, technical acumen, communication skills and strategic thinking, along with the ability to work independently and cross-functionally.
Associate Director/Senior Manager Regulatory Affairs Precigen IncAssociate Director/Senior Manager Regulatory AffairsGermantown, MDParticipation in project team and sub team discussions regarding preclinical, clinical and CMC aspects of drug development, providing regulatory guidance, communicating regulatory goals and timelines, and helping to ensure compliance to the requirements from U.S. and foreign regulatory agencies. The Associate Director/Senior Manager will interact with all aspects of Precigen's quality, CMC, preclinical, and clinical drug development programs, policies, and procedures ensuring compliance is maintained with all regulatory commitments/requirements.
Senior Regulatory & Scientific Affairs Specialist (Remote) Nestle SASenior Regulatory & Scientific Affairs Specialist (Remote)Arlington, VARemote$99,500–$130,000 / yearIf you live within 50 miles of our Arlington, VA, headquarters, this will be a hybrid position currently requiring Tuesday-Thursday onsite This will support International Premium Waters Position Summary Apply experience and expertise of regulations & policies to review and apply compliance by design of (a) formulas, ingredients and any relevant processing procedures, (b) all required and optional label information, including claims, and (c) sensitive communications such as advertising, promotional materials, websites, etc. Must demonstrate strong verbal and written communications skills, along with strong influencing and negotiation skills, recognized expertise in functional areas with the ability to communicate regulatory and technical issues in lay terms.
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution AstraZeneca PlcAssociate Director, Regulatory Affairs US Lead, Regulatory Science & ExecutionGaithersburg, MD$135,624.80–$203,437.20 / yearThe Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. Providing strategic and tactical advice on regulatory issues for pipeline products; actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
Senior Director, Head of US Regulatory Affairs Policy & Intelligence Teva Pharmaceutical Industries LtdSenior Director, Head of US Regulatory Affairs Policy & IntelligenceWashington, WA$248,000–$310,000 / yearAdditional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. This role combines senior‑level regulatory policy leadership, regulatory intelligence, and external advocacy, with accountability for shaping US regulatory outcomes, enabling development and portfolio strategy, and strengthening Teva's influence and credibility with FDA and key stakeholders.
Senior Regulatory Affairs Specialist (Columbia, MD) Smith & Nephew PlcSenior Regulatory Affairs Specialist (Columbia, MD)Columbia, MD$101,500–$152,250 / yearp>The Senior Regulatory Affairs Specialist will be responsible for projects by leading regulatory submissions and designing comprehensive regulatory strategies on Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/P) projects as well as define regulatory strategies for new device-led combination products. Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
Regulatory Affairs Specialist US Department of Health and Human ServicesRegulatory Affairs SpecialistMontgomery County, MD$121,785–$158,322 / yearIn addition, to qualify for a Regulatory Affairs Specialist GS-0601 position at the GS-13 grade level, you must have: at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: (1) Leading protocol navigation activities, including coordinating scientific review, Institutional Review Board (IRB) and/or Investigational New Drug (IND) submissions, addressing stipulations, and facilitating clinical trial protocol development processes; (2) Managing a clinical trials portfolio by liaising with investigators/ study teams, regulatory agencies, and sponsors; tracking reviews of all review bodies; and maintaining accurate essential regulatory documentation; (3) Developing regulatory documents such as protocols, consents, and associated components in accordance with federal regulatory requirements; (4) Providing regulatory expertise by analyzing complex issues, preparing safety, annual, and/or progress reports, and recommending strategies to ensure compliance and expedite review processes. Assist all aspects of the protocol lifecycle including scientific review, initial investigational new drug (IND) documents, institutional review board (IRB) submission of protocols, continuing review applications, protocol amendments, annual reports to other regulatory and safety bodies such as the Radiation Safety Committee (RSC) and the Institutional Biosafety Committee (IBC), and protocol inactivation.
Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution Alexion Pharmaceuticals IncAssociate Director, Regulatory Affairs US Lead, Regulatory Science & ExecutionGaithersburg, MD$135,624.80–$203,437.20 / yearp>The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. Providing strategic and tactical advice on regulatory issues for pipeline products; actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyRockville, MDp>US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Director Promotional Regulatory Affairs AstraZeneca PlcDirector Promotional Regulatory AffairsGaithersburg, MDDesirable Skills/Experience: • Advanced degree in life sciences, pharmacy, law, or a related discipline • 10 or more years of experience in US promotional regulatory affairs within biopharma, including direct OPDP/APLB interactions and resolution of advisory or enforcement matters • Experience leading or co-chairing MLR processes and operating within digital review systems such as AZAP or comparable platforms • Launch-to-lifecycle leadership across HCP and consumer promotions, managed markets materials, and omnichannel/digital campaigns • Proven ability to design and deliver effective regulatory training for commercial and medical stakeholders • Demonstrated influence at senior levels to shape departmental practices and operational plans • People leadership experience with a track record of coaching and building high-performing teams. Essential Skills/Experience: • Bachelor's degree in science • 3+ years' experience in promotional regulatory affairs, FDA (OPDP/APLB), or other equivalent experience in advertising and promotion review • 5+ years total experience in pharmaceutical/biotech industry, FDA, or equivalent experience • Strong knowledge of FDA promotional regulations and ability to apply such knowledge in review of diverse promotional materials and audiences • Knowledge of the drug development and labeling processes.
Vice President, Global Head of Regulatory Affairs Qiagen NVVice President, Global Head of Regulatory AffairsGermantown, MDCreate practical solutions to complex regulatory challenges by setting policies and procedures, aligning cross-functional teams, and maintaining strong working relationships with government and non-government organizations that affect market access and distribution. Strategic experience and ability, having demonstrated success related to the development and implementation of pre-clinical and clinical strategies for clinical IVD products, implementation of regulatory systems, and assuring compliance to all applicable regulations.
Regulatory Affairs Director AstraZeneca PlcRegulatory Affairs DirectorGaithersburg, MD$178,534–$267,801 / yearp>Competitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles).
Regulatory Affairs Strategy Director AstraZeneca PlcRegulatory Affairs Strategy DirectorGaithersburg, MD$186,232.80–$279,349.20 / yearp>Competitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. The more experienced you are, the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.
Director of Regulatory Affairs,Tactical and Implementation Immunocore Holdings PlcDirector of Regulatory Affairs,Tactical and ImplementationGaithersburg, MD$157,500–$262,500 / yearp>Experience & knowledge Essential: • Solid track record in drug development and leadership within a dynamic project team • Emerging understanding of global regulatory requirements to be able to formulate tactical regulatory strategies • Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally • Emerging ability to propose scientific regulatory strategies that are reviewed with line management for concurrence and approval • Excellent knowledge of US regulatory requirements and experience with submissions gained within drug development. The individual will also be assigned projects and regulatory activities by providing expertise to Immunocores development programs to include regulatory implementation of regulatory strategies, IND developments, submission, maintenance, tracking BLAs, BLA planning, submission, maintenance, tracking agency liaison for specific tactical assignments and regulatory intelligence for tactical process-related changes in requirements.
Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcExecutive Director, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MD$276,127–$414,190 / yearp>Milestone Delivery and Dossier Excellence: Be accountable for delivery of all project-related regulatory milestones, including probability of regulatory success assessments, mitigation planning, approval strategy, lifecycle planning; lead preparation of regulatory strategy documents and target product labeling; ensure strong strategic planning and construction of the global dossier and core prescribing information; oversee maintenance and compliance for marketed brands where applicable. Accountabilities: Global Regulatory Strategy Leadership: Own the end-to-end global regulatory strategy for a cell and gene therapy product or franchise of exceptional complexity and strategic importance, from current stage through BLA submission, approval, and lifecycle management; may serve in a dual role as Franchise GRL and regional Regulatory Affairs Director.
Vice President, Regulatory Affairs *PC 884 Miltenyi Biotec GmbHVice President, Regulatory Affairs *PC 884Gaithersburg, MD$295,600–$347,764 / yearp>Your Role: The role will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts.?The role will oversee industry-specific practices, ensure all government and company regulations are being met, assessing regulatory risks and interfacing with regulatory authorities to ensure the company meets all set requirements and guidance's. Lead team members that provide regulatory affairs content and requirements for regulatory submissions and review this content for conformance with established requirement.?Manage and develop staff, if required, including staff professional development and project oversight accountability.?.
Manager, Regulatory Affairs - Advertising and Promotion Supernus Pharmaceuticals IncManager, Regulatory Affairs - Advertising and PromotionRockville, MD$100,000–$140,000 / yearp>Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. The worker is required to have close visual acuity to perform an activity such as preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistDC$99,000–$157,000 / yearp>The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. • Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
NewRegulatory Affairs Manager AstraZeneca PlcRegulatory Affairs ManagerGaithersburg, MD$109,245–$163,867 / yearli>Integrated Project Management: Develop, execute and maintain submission delivery plans and content plans; proactively provide status updates to stakeholders; coordinate input, maintenance and revisions in Planit project plans; highlight unforeseen changes in resource demand to the Lead RPM and line manager. Submission Leadership: Lead and contribute to planning, preparation (including authoring where relevant) and delivery of simple and, with experience, increasingly complex submissions throughout the product lifecycle from global and/or regional perspectives; connect immediate deliverables to future label and lifecycle opportunities.
NewStrategy Lead, CMC Mature, Regulatory Affairs GSK plcStrategy Lead, CMC Mature, Regulatory AffairsRockville, MD$113,850–$189,750 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
Vice President, MedTech Cardiovascular Regulatory Affairs IQVIAVice President, MedTech Cardiovascular Regulatory AffairsWashington, District of Columbiap>The Vice President, MedTech Cardiovascular Regulatory Affairs will be a critical team member and Company leader supporting regulatory strategy and submissions for the firm’s clientele, and managing and leading their domain specific department, as required. Develop and execute regulatory services for client companies, including however not limited to:Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs) Regulatory Strategy, Analysis & Development.
Sr. Regulatory Affairs Analyst - Medical Devices Tunnell Government ServicesSr. Regulatory Affairs Analyst - Medical DevicesWashington, DCdiv class="content-intro">Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. For more information on BARDA please visit their website at: https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx and specifically the Division of Regulatory and Quality Affairs: https://medicalcountermeasures.gov/barda/rqa.Regulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerBaltimore, MDli> Provide leadership to Subject Matter Experts (SMEs) in multidisciplinary teams and manage day to-day operations of project tasks/activities to ensure deliverables are met in a timely manner within budget. Experience with multiple electronic software/platforms (such as Vantagepoint, Starting Point templates (or similar regulatory templates), Smartsheet, MS Office suite or other project management programs).CMC REGULATORY AFFAIRS CONSULTANT (SENIOR-LEVEL) SciLucent LLCCMC REGULATORY AFFAIRS CONSULTANT (SENIOR-LEVEL)Herndon, VARemote$115,000–$215,000 / yearOur scientific/regulatory consulting team is expanding, and we are seeking a mid-level experienced scientific professional with a strong CMC Regulatory Affairs background to join our team of experienced professional consultants. We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.Regulatory Affairs Manager V Goldbelt IncorporatedRegulatory Affairs Manager VFort Detrick, MDTPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with Regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in accordance with approved business rules in the assigned electronic document management system. Summary: The Regulatory Affairs Manager V will work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts.Associate General Counsel, U.S. Government Affairs and Regulatory ViaSat IncAssociate General Counsel, U.S. Government Affairs and RegulatoryDC$242,500–$363,500 / yearAdvancing company positions in preparation for and on U.S. delegations to spectrum-related international conferences and meetings (e.g., ITU WRCs and Study Groups, CITEL PCC II, and related preparatory meetings), and in trade association discussions. For specific work locations within San Jose, the San Francisco Bay area, and New York City metropolitan area, the base pay range for this role is $242,500.00- $363,500.00/ annually.Head of US Regulatory Affairs Advertising and Promotion Viatris IncHead of US Regulatory Affairs Advertising and PromotionDC$151,000–$314,000 / yearWith a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. Serve as the primary contact with the FDA's Office of Prescription Drug Promotion (OPDP) within the U.S. Food and Drug Administration; lead submissions, risk mitigation strategies, and regulatory interactions including advisory comments, Form FDA 2253 submissions, and responses to regulatory enforcement actions.Director of Regulatory Affairs, Satellite Policy Blue Origin Enterprises LPDirector of Regulatory Affairs, Satellite PolicyArlington, VAp>Qualifications: • 10+ years in satellite policy, regulatory affairs, or telecom law within the satellite or aerospace sector • Strong network of relationships across government agencies, space industry bodies, and regulatory institutions • Deep knowledge of FCC and ITU frameworks and procedures • Knowledge of orbital debris mitigation policy and space sustainability frameworks • Strong experience reporting to executive teams and boards, including preparation of regulatory or strategy briefings • Demonstrated success leading teams and working cross-functionally • Track record of representing organizations at high-level international policy forums (e.g., WRC, UN COPUOS) • Willingness to travel approximately 25% of the time. Preferred Skills & Experience: • Leadership experience with global satellite operators, launch providers, or legal/regulatory advisory firms • MBA, MSEE, JD, or equivalent advanced degree in a related field • Technical expertise in RF engineering, satellite systems, and/or inter-satellite links • Experience with spectrum requirements for commercial space launch, lunar operations • Background in national security space policy and ITAR/EAR compliance • Proven ability to navigate complex multi-stakeholder regulatory challenges • Experience leading through organizational growth and transformation.Executive Director, Regulatory Affairs JPMorgan Chase & CoExecutive Director, Regulatory AffairsDCOur history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. JPMorgan Chase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world's most prominent corporate, institutional and government clients under the J.P.Government Affairs Director - Global Spectrum Policy & Regulatory Affairs Motorola Solutions IncGovernment Affairs Director - Global Spectrum Policy & Regulatory AffairsVA$220,000–$230,000 / yearp>As a Government Affairs Director, Spectrum Policy & Regulatory Affairs you will be responsible for: Developing and implementing spectrum policy and regulatory positions in support of MSI business goals and objectives, coordinating MSI spectrum and regulatory strategies between different regulatory regimes, balancing the differences in spectrum availability and regulations between countries to advance MSI interests. Represent MSI externally at regional and international spectrum conferences such as the World Radio Conference, and at industry, public safety and other trade association conferences and meetings (e.g., TIA, EWA, IWCE, APCO) acting as the face of MSI on such issues.Director - US Regulatory Affairs Fresenius Medical CareDirector - US Regulatory AffairsWashington, District of ColumbiaThe Director will serve as a key connector across Government Affairs, business leaders, and subject matter experts to inform decision-making and drive effective engagement with federal agencies. The Director of U.S. Regulatory Affairs is a strategic leader responsible for providing expert regulatory guidance to support the development and execution of public policy initiatives and federal agency engagement strategies.Director, Regulatory Affairs - Neurology MedTech IQVIADirector, Regulatory Affairs - Neurology MedTechWashington, District of ColumbiaThe primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas, as applicable. Develop and execute regulatory services for client companies, including however not limited to: Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs).NewManager, CMC Vaccines Mature Projects, Regulatory Affairs GSK plcManager, CMC Vaccines Mature Projects, Regulatory AffairsRockville, MD$113,850–$189,750 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.Regulatory Affairs Intern EnergyHubRegulatory Affairs InternWashington, DC$24–$25 / hourWe collect and use those categories of Personal Information about you for human resources and other business management purposes, including identifying and evaluating you as a candidate for potential or future employment or future positions, recordkeeping in relation to recruiting and hiring, conducting analytics, and ensuring compliance with applicable legal requirements and Company policies. Work with the latest technologies: You'll gain exposure to a broad spectrum of IoT, SaaS and machine learning obstacles, including distributed fault-tolerance, device control optimization, and process modeling to support scalable interaction with disparate downstream APIs.Regulatory, Public Policy, and Government Affairs Associate Managing Director Graham Inc.Regulatory, Public Policy, and Government Affairs Associate Managing DirectorWashington, DC$100,000–$125,000 / yearBy attracting, supporting, promoting and retaining highly qualified individuals of various backgrounds and experiences, they strengthen the ability to provide innovative solutions, deliver exceptional client service, and advance the success of their Firm. Expected responsibilities will include, but will not be limited to: Supporting the our client's Federal Public Policy team of on all their clients and projects related to natural resources and water policy issues, tracking developments on legislation and regulations, and advising on related strategy.Executive Director, Regulatory Affairs Precigen IncExecutive Director, Regulatory AffairsGermantown, MDThis role is responsible for defining regulatory strategy, planning and the preparation of US and eventually global regulatory submissions to achieve timely approvals of biologic licensing and marketing authorization applications and post-approval lifecycle changes for Precigen CAR-T and AdenoVerse immunotherapy Products. We are seeking a global Executive Director, Regulatory Affairs (level determined by candidate experience) reporting into the SVP Regulatory Affairs who is responsible for oversight of IND/IMPD, BLA and ex-US activities for the CAR-T and immunotherapy products.General Counsel & Head of Regulatory Affairs Quantic School of Business and TechnologyGeneral Counsel & Head of Regulatory AffairsWashington, DC$235,000–$285,000ul>Higher-education regulatory affairs: Manage state authorization across all jurisdictions where students are located, including renewals and reporting with the DC Higher Education Licensure Commission (HELC), the California BPPE, the Alabama Commission on Higher Education (ACHE), and NC-SARA. Track federal rulemaking affecting higher education, both during the negotiated rulemaking phase, where stakeholder coordination shapes the proposed rule, and through the NPRM, comment, and final rule phases, and translate outcomes into operational requirements for the business.Regulatory Affairs Specialist - WHIRC The Henry M Jackson Foundation for the Advancement of Military Medicine IncRegulatory Affairs Specialist - WHIRCAnnandale, VAp>HJF is seeking a Regulatory Affairs Specialist-WHIRC to be responsible for assisting in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects' research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.12345678910Resume ResourcesFree Resume TemplatesFree Resume Builder
Regulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerBaltimore, MDli> Provide leadership to Subject Matter Experts (SMEs) in multidisciplinary teams and manage day to-day operations of project tasks/activities to ensure deliverables are met in a timely manner within budget. Experience with multiple electronic software/platforms (such as Vantagepoint, Starting Point templates (or similar regulatory templates), Smartsheet, MS Office suite or other project management programs).
CMC REGULATORY AFFAIRS CONSULTANT (SENIOR-LEVEL) SciLucent LLCCMC REGULATORY AFFAIRS CONSULTANT (SENIOR-LEVEL)Herndon, VARemote$115,000–$215,000 / yearOur scientific/regulatory consulting team is expanding, and we are seeking a mid-level experienced scientific professional with a strong CMC Regulatory Affairs background to join our team of experienced professional consultants. We offer a congenial, supportive, and flexible work environment, the opportunity to work with knowledgeable consultants, and the ability to develop a tremendous amount of knowledge and expertise across many stages and areas of healthcare product development.
Regulatory Affairs Manager V Goldbelt IncorporatedRegulatory Affairs Manager VFort Detrick, MDTPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with Regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in accordance with approved business rules in the assigned electronic document management system. Summary: The Regulatory Affairs Manager V will work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts.
Associate General Counsel, U.S. Government Affairs and Regulatory ViaSat IncAssociate General Counsel, U.S. Government Affairs and RegulatoryDC$242,500–$363,500 / yearAdvancing company positions in preparation for and on U.S. delegations to spectrum-related international conferences and meetings (e.g., ITU WRCs and Study Groups, CITEL PCC II, and related preparatory meetings), and in trade association discussions. For specific work locations within San Jose, the San Francisco Bay area, and New York City metropolitan area, the base pay range for this role is $242,500.00- $363,500.00/ annually.
Head of US Regulatory Affairs Advertising and Promotion Viatris IncHead of US Regulatory Affairs Advertising and PromotionDC$151,000–$314,000 / yearWith a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. Serve as the primary contact with the FDA's Office of Prescription Drug Promotion (OPDP) within the U.S. Food and Drug Administration; lead submissions, risk mitigation strategies, and regulatory interactions including advisory comments, Form FDA 2253 submissions, and responses to regulatory enforcement actions.
Director of Regulatory Affairs, Satellite Policy Blue Origin Enterprises LPDirector of Regulatory Affairs, Satellite PolicyArlington, VAp>Qualifications: • 10+ years in satellite policy, regulatory affairs, or telecom law within the satellite or aerospace sector • Strong network of relationships across government agencies, space industry bodies, and regulatory institutions • Deep knowledge of FCC and ITU frameworks and procedures • Knowledge of orbital debris mitigation policy and space sustainability frameworks • Strong experience reporting to executive teams and boards, including preparation of regulatory or strategy briefings • Demonstrated success leading teams and working cross-functionally • Track record of representing organizations at high-level international policy forums (e.g., WRC, UN COPUOS) • Willingness to travel approximately 25% of the time. Preferred Skills & Experience: • Leadership experience with global satellite operators, launch providers, or legal/regulatory advisory firms • MBA, MSEE, JD, or equivalent advanced degree in a related field • Technical expertise in RF engineering, satellite systems, and/or inter-satellite links • Experience with spectrum requirements for commercial space launch, lunar operations • Background in national security space policy and ITAR/EAR compliance • Proven ability to navigate complex multi-stakeholder regulatory challenges • Experience leading through organizational growth and transformation.
Executive Director, Regulatory Affairs JPMorgan Chase & CoExecutive Director, Regulatory AffairsDCOur history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. JPMorgan Chase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world's most prominent corporate, institutional and government clients under the J.P.
Government Affairs Director - Global Spectrum Policy & Regulatory Affairs Motorola Solutions IncGovernment Affairs Director - Global Spectrum Policy & Regulatory AffairsVA$220,000–$230,000 / yearp>As a Government Affairs Director, Spectrum Policy & Regulatory Affairs you will be responsible for: Developing and implementing spectrum policy and regulatory positions in support of MSI business goals and objectives, coordinating MSI spectrum and regulatory strategies between different regulatory regimes, balancing the differences in spectrum availability and regulations between countries to advance MSI interests. Represent MSI externally at regional and international spectrum conferences such as the World Radio Conference, and at industry, public safety and other trade association conferences and meetings (e.g., TIA, EWA, IWCE, APCO) acting as the face of MSI on such issues.
Director - US Regulatory Affairs Fresenius Medical CareDirector - US Regulatory AffairsWashington, District of ColumbiaThe Director will serve as a key connector across Government Affairs, business leaders, and subject matter experts to inform decision-making and drive effective engagement with federal agencies. The Director of U.S. Regulatory Affairs is a strategic leader responsible for providing expert regulatory guidance to support the development and execution of public policy initiatives and federal agency engagement strategies.
Director, Regulatory Affairs - Neurology MedTech IQVIADirector, Regulatory Affairs - Neurology MedTechWashington, District of ColumbiaThe primary roles and responsibilities include managing the development of regulatory submissions, development of overall regulatory strategy, communicating with regulatory bodies and clients, and leading or expanding new therapy ideas, as applicable. Develop and execute regulatory services for client companies, including however not limited to: Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs).
NewManager, CMC Vaccines Mature Projects, Regulatory Affairs GSK plcManager, CMC Vaccines Mature Projects, Regulatory AffairsRockville, MD$113,850–$189,750 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
Regulatory Affairs Intern EnergyHubRegulatory Affairs InternWashington, DC$24–$25 / hourWe collect and use those categories of Personal Information about you for human resources and other business management purposes, including identifying and evaluating you as a candidate for potential or future employment or future positions, recordkeeping in relation to recruiting and hiring, conducting analytics, and ensuring compliance with applicable legal requirements and Company policies. Work with the latest technologies: You'll gain exposure to a broad spectrum of IoT, SaaS and machine learning obstacles, including distributed fault-tolerance, device control optimization, and process modeling to support scalable interaction with disparate downstream APIs.
Regulatory, Public Policy, and Government Affairs Associate Managing Director Graham Inc.Regulatory, Public Policy, and Government Affairs Associate Managing DirectorWashington, DC$100,000–$125,000 / yearBy attracting, supporting, promoting and retaining highly qualified individuals of various backgrounds and experiences, they strengthen the ability to provide innovative solutions, deliver exceptional client service, and advance the success of their Firm. Expected responsibilities will include, but will not be limited to: Supporting the our client's Federal Public Policy team of on all their clients and projects related to natural resources and water policy issues, tracking developments on legislation and regulations, and advising on related strategy.
Executive Director, Regulatory Affairs Precigen IncExecutive Director, Regulatory AffairsGermantown, MDThis role is responsible for defining regulatory strategy, planning and the preparation of US and eventually global regulatory submissions to achieve timely approvals of biologic licensing and marketing authorization applications and post-approval lifecycle changes for Precigen CAR-T and AdenoVerse immunotherapy Products. We are seeking a global Executive Director, Regulatory Affairs (level determined by candidate experience) reporting into the SVP Regulatory Affairs who is responsible for oversight of IND/IMPD, BLA and ex-US activities for the CAR-T and immunotherapy products.
General Counsel & Head of Regulatory Affairs Quantic School of Business and TechnologyGeneral Counsel & Head of Regulatory AffairsWashington, DC$235,000–$285,000ul>Higher-education regulatory affairs: Manage state authorization across all jurisdictions where students are located, including renewals and reporting with the DC Higher Education Licensure Commission (HELC), the California BPPE, the Alabama Commission on Higher Education (ACHE), and NC-SARA. Track federal rulemaking affecting higher education, both during the negotiated rulemaking phase, where stakeholder coordination shapes the proposed rule, and through the NPRM, comment, and final rule phases, and translate outcomes into operational requirements for the business.
Regulatory Affairs Specialist - WHIRC The Henry M Jackson Foundation for the Advancement of Military Medicine IncRegulatory Affairs Specialist - WHIRCAnnandale, VAp>HJF is seeking a Regulatory Affairs Specialist-WHIRC to be responsible for assisting in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects' research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.