NewAssociate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteWashington DC, DCRemote$153,541–$230,312 / yearli>The current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
NewSenior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteWashington DC, DCRemote$131,035–$196,553 / yearli>Manage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.
NewDirector, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteWashington DC, DCRemote$183,549–$275,324 / yearli>The current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
NewSenior Oncology Account Manager, Hematology - Washington, D.C. Jazz PharmaceuticalsSenior Oncology Account Manager, Hematology - Washington, D.C.Washington, DCRemote$155,200–$232,800 / yearul>Educate physicians and other health care professionals about Jazz Pharmaceuticals product(s), providing the most current information about the approved indications for the company’s products within the current disease areas of focus: pediatric and young adult acute lymphoblastic leukemia (ALL) and bone marrow transplant. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
NewMedical Science Liaison, Neuro-Oncology, Mid-Atlantic Jazz PharmaceuticalsMedical Science Liaison, Neuro-Oncology, Mid-AtlanticWashington, DCRemote$160,000–$240,000 / yearThe successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. This is a field-based position covering Connecticut, New York City, New Jersey, Delaware, Maryland, Washington DC, Virginia, West Virginia, North Carolina and requires professionals with established personal and scientific credibility to interact with thought leaders and academic centers of excellence.
NewAssociate Director/ Director, Patient Marketing - Remote Agios PharmaceuticalsAssociate Director/ Director, Patient Marketing - RemoteWashington DC, DCRemote$183,549–$275,324 / yearli>The current base salary range for this position at the Associate Director level is expected to be between $153,541 and $230,312 annualized and the current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. The Associate Director/Director, Patient Marketing will focus on developing and executing the patient strategy in preparation for the future launch of mitapivat, currently in development for sickle cell disease, a vastly underserved community.
NewAssociate Director, Scientific Communications & Publications - Remote Agios PharmaceuticalsAssociate Director, Scientific Communications & Publications - RemoteWashington DC, DCRemote$153,000–$230,000 / yearOperating at the intersection of strategy and execution, this role partners closely with cross-functional colleagues and external experts to deliver high‑impact publications and scientific communications that advance both patient care and scientific dialogue. The current base salary range for this position is expected to be between $153,000 and $230,000 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
NewMedical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentWashington DC, DC$221,600–$369,333 / yearli>The current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
NewTechnical 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..
NewAssociate Director, Patient Advocacy – Patient Community Ambassador (Mid-Atlantic or South) Agios PharmaceuticalsAssociate Director, Patient Advocacy – Patient Community Ambassador (Mid-Atlantic or South)Washington DC, DC$153,541–$230,312 / yearli>The current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Identify opportunities to build and strengthen relationships with local patients, patient support groups, advocacy organizations, and multicultural centers to ensure we better understand the needs of the patient communities.
NewAssociate Director, Federal Policy Agios PharmaceuticalsAssociate Director, Federal PolicyWashington, DCRemote$153,541–$230,312 / yearli>The current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
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.).
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.
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.
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.
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 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. Site Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, USA - Maryland - Rockville, USA - Massachusetts - Waltham Posted Date: Jun 9 2026 Associate Director Regulatory Affairs, Oncology At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade.
NewExecutive Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcExecutive Director, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MDp>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.
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.
Associate Director/Senior Manager Regulatory Affairs Precigen IncAssociate Director/Senior Manager Regulatory AffairsGermantown, MDli>Participation 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 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 & 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.
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.
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 / 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.).
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 - ImmunologyDCp>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.
NewSenior Regulatory Affairs Manager Katalyst Healthcares and Life SciencesSenior Regulatory Affairs ManagerColumbia, MDli> ssists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness, accuracy, and accessibility of records related to QOL initiatives. Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
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.
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.
NewSenior Regulatory Affairs Manager Katalyst Healthcares & Life SciencesSenior Regulatory Affairs ManagerColumbia, MDp>Assists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness, accuracy, and accessibility of records related to QOL initiatives. Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
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/).
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.?.
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.NewRegulatory Affairs Coordinator - VESPER The Henry M Jackson Foundation for the Advancement of Military Medicine IncRegulatory Affairs Coordinator - VESPERWashington, DCThe Regulatory Affairs Coordinator will support the center's human subjects research portfolio focused on environmental exposures and health outcomes, by preparing, submitting, and managing regulatory documentation; ensuring compliance with institutional, federal, and sponsor requirements; and assisting with study budget and supply management. This role is responsible for Institution Review Board (IRB) submissions, informed consent oversight, regulatory documentation management, supply tracking, ongoing study compliance, supply inventory, and study budget oversight.NewSenior Regulatory Affairs Scientist VenescoSenior Regulatory Affairs ScientistFalls Church, VAJoin a dynamic regulatory team as a Senior Regulatory Affairs Scientist, where you will lead submission strategies and regulatory interactions for innovative medical products. QualificationsAdvanced degree in regulatory science, biology, or related field .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.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 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.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.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.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.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.Regulatory 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.Government Affairs Director - Global Spectrum Policy & Regulatory Affairs Motorola Solutions IncGovernment Affairs Director - Global Spectrum Policy & Regulatory AffairsMD$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.12345678910Resume ResourcesFree Resume TemplatesFree Resume BuilderSimilar Job SearchesGovernment Agencies JobsLocal Government JobsRegulatory Affairs JobsRegulatory Affairs JobsRemote GovernmentEntry Level Government
NewRegulatory Affairs Coordinator - VESPER The Henry M Jackson Foundation for the Advancement of Military Medicine IncRegulatory Affairs Coordinator - VESPERWashington, DCThe Regulatory Affairs Coordinator will support the center's human subjects research portfolio focused on environmental exposures and health outcomes, by preparing, submitting, and managing regulatory documentation; ensuring compliance with institutional, federal, and sponsor requirements; and assisting with study budget and supply management. This role is responsible for Institution Review Board (IRB) submissions, informed consent oversight, regulatory documentation management, supply tracking, ongoing study compliance, supply inventory, and study budget oversight.
NewSenior Regulatory Affairs Scientist VenescoSenior Regulatory Affairs ScientistFalls Church, VAJoin a dynamic regulatory team as a Senior Regulatory Affairs Scientist, where you will lead submission strategies and regulatory interactions for innovative medical products. QualificationsAdvanced degree in regulatory science, biology, or related field .
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.
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 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.
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.
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.
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.
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.
Regulatory 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.
Government Affairs Director - Global Spectrum Policy & Regulatory Affairs Motorola Solutions IncGovernment Affairs Director - Global Spectrum Policy & Regulatory AffairsMD$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.