NewMaterials Planning Manager (Hybrid) SOFIEMaterials Planning Manager (Hybrid)Dulles, VA$130,000–$140,000 / yearBenefits include: Hybrid Flexibility: This role operates on a hybrid schedule, requiring two days per week on-site (Tuesday & Wednesday) at our state-of-the-art facility in Dulles, VA, with the remaining three days working remotely. Cross-Functional Collaboration: Partner closely with Production, Quality Assurance, Regulatory Affairs, and specialized Logistics/Distribution teams to ensure requirements are met and product flow from raw material to patient delivery is seamless.
NewTechnical Writer Sparks GroupTechnical WriterWashington, DC$40–$45 / hourDownload the Sparks Group mobile app from Apple App Store or Google Play . Proficient in the use of the Microsoft Office Suite and software tools necessary to create and maintain documentation.
Human Resources Manager Shred-Tech Asia Co., Ltd.Human Resources ManagerSriracha, CHOEnsure 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.).
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRockville, MD$190,800–$300,300 / yearRequired 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 / yearThe 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.
Senior Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcSenior Director, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MD$218,058–$327,087 / yearAccountabilities: 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.
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.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRockville, MD$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Satellite Policy Associate Starlink Regulatory Affairs Space Exploration Technologies CorpSatellite Policy Associate Starlink Regulatory AffairsDC$150,000–$215,000 / yearRESPONSIBILITIES: • 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 Affairs Specialist (Columbia, MD) Smith & Nephew PlcSenior Regulatory Affairs Specialist (Columbia, MD)Columbia, MD$101,500–$152,250 / yearThe 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. Act as NPD regulatory lead on new device-biologics combination products and define regulatory strategy for FDA submissions including authoring FDA 510(k) submissions and FDA pre-submissions.
Director, Regulatory Affairs CTIADirector, Regulatory AffairsWashingtonJob title: Director, Regulatory Affairs Department: Regulatory Affairs Reports to: Senior Vice President, Regulatory Affairs Salary Range: $150,000 - $205,000 Summary: The Director, Regulatory Affairs works to advance the Regulatory Affairs Department’s mission of promoting the wireless industry’s positions on Federal regulatory policy issues on behalf of, and in coordination with, CTIA’s members. The Director works as part of the Regulatory Affairs team to monitor regulatory activity, coordinate calls and meetings, develop advocacy documents such as comments and letters, help the team prepare for panels and hearings, develop presentations, and provide other assistance as needed.
NewRegulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerWashington DC, DCThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
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. Qualifications Advanced degree in regulatory science, biology, or related field.
Scientific Program Manager (Regulatory Affairs) (51824) Gap Solutions, Inc.Scientific Program Manager (Regulatory Affairs) (51824)Bethesda, MDThese documents include, but are not limited to, clinical study protocols, informed consent documents, to ensure test plans encompass all required test elements, data parameters, test objectives, chemistry manufacturing and control (CMC) documents, and nonclinical study report summaries. Manage complex systems for data management and document control; supporting the dissemination of information on vaccine, monoclonal antibody, and other VRC clinical trials and collaborations using VRC products; and responds to related inquiries by sites, sponsors, FDA, and international regulatory agencies.
Executive Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcExecutive Director, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MD$276,127–$414,190 / yearMilestone 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.
OGC | Counsel | Disputes Consultant & Regulatory Affairs (DCRA) Deloitte Touche Tohmatsu LtdOGC | Counsel | Disputes Consultant & Regulatory Affairs (DCRA)Washington, DC$205,700–$342,900 / yearProvides critical analysis of issues surrounding document preservation, confidentiality, privilege, client relations, timing, jurisdiction, legal risk, negotiation strategies, compliance matters and/or the need for consultation with the Office of General Counsel (OGC) leadership, DTTL counsel, and/or risk management. The attorney will be responsible for all aspects of each matter, including reviewing the request, preparing any necessary objections and responses, working with legal assistants and fact witnesses to identify relevant information, and providing documents and defending depositions to the extent required.
Manager, Regulatory Affairs - Advertising and Promotion Supernus Pharmaceuticals IncManager, Regulatory Affairs - Advertising and PromotionRockville, MD$100,000–$140,000 / yearSupernus 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.
NewSenior Regulatory Affairs Manager Katalyst Healthcares and Life SciencesSenior Regulatory Affairs ManagerColumbia, MDssists 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.
NewSenior Regulatory Affairs Manager Katalyst Healthcares & Life SciencesSenior Regulatory Affairs ManagerColumbia, MDAssists 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.
Regulatory Affairs Manager AstraZeneca PlcRegulatory Affairs ManagerGaithersburg, MD$109,245–$163,867 / yearIntegrated 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.
Strategy 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.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyRockville, MDApplicable 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. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
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.
Director of Regulatory Affairs,Tactical and Implementation Immunocore Holdings PlcDirector of Regulatory Affairs,Tactical and ImplementationGaithersburg, MD$157,500–$262,500 / yearExperience & 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.
NewSenior Manager, Regulatory Affairs Getinge ABSenior Manager, Regulatory AffairsWashington D.C., DCRemoteThe Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making.
Sr. Director/Director of Regulatory Affairs, Chemical & Environment KellenSr. Director/Director of Regulatory Affairs, Chemical & EnvironmentWashingtonInterested candidates should have a strong understanding of the chemical & environmental policy space regarding technical and regulatory processes as this individual will play a crucial role in representing client priorities and ensuring that client policies and positions are effectively communicated to government officials and other relevant stakeholders. The position is responsible for coordinating and delivering a wide range of member-driven initiatives across advocacy, technical programs, and industry engagement including the development of industry positions and proposals, participation in hearings, and engagement with regulators, stakeholders, and industry coalitions. .
Regulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerBaltimore, MDProvide 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).
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.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistDC$99,000–$157,000 / yearThe 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.
Sr. Regulatory Affairs Analyst - Medical Devices Tunnell Government ServicesSr. Regulatory Affairs Analyst - Medical DevicesWashington, DCMinimum 15 years of device development; Government or industry experience in regulatory and/or quality affairs for diagnostic devices, particularly seeking expertise with imaging devices, software as a medical device, in vitro diagnostic devices, wearable technologies, digital health, and home use diagnostics. Duties of the position: This position will serve as regulatory affairs subject matter expert for multiple BARDA programs and projects involving development and manufacturing of in vitro diagnostic and device medical countermeasures specific to influenza, emerging infectious disease, CBRN threats (e.g.
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.
Regulatory 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.
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, VAQualifications: • 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.
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).
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.
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.
Manager, Regulatory Affairs - Advertising and Promotion Supernus PharmaceuticalsManager, Regulatory Affairs - Advertising and PromotionRockville, MarylandSupernus 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.
Government Affairs Director - Global Spectrum Policy & Regulatory Affairs Motorola Solutions IncGovernment Affairs Director - Global Spectrum Policy & Regulatory AffairsDC$220,000–$230,000 / yearAs 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.
NewSenior Manager, Regulatory Affairs Mema llcSenior Manager, Regulatory AffairsWashington, DCIn collaboration with the Vice President, Regulatory Affairs, the Senior Manager advances MEMA's policy priorities, strengthens relationships with regulators and industry stakeholders, and helps ensure members are informed, engaged, and well positioned to navigate a fast-paced and evolving regulatory environment. The Senior Manager, Regulatory Affairs is an integral member of MEMA's Government Affairs team and supports the association's advocacy efforts by leading engagement on federal, state, and international regulatory issues affecting the motor vehicle supplier industry.
NewRegulatory Affairs Specialist (North America, LATAM, EU) AlimentivRegulatory Affairs Specialist (North America, LATAM, EU)Baltimore, MarylandRepresent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client. Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices, communicating changes to project leaders in a timely manner.
Director, Regulatory Affairs Strategy - Cell and Gene Therapy AstraZeneca PlcDirector, Regulatory Affairs Strategy - Cell and Gene TherapyGaithersburg, MD$186,232–$279,349 / yearPartnering with senior leaders and global teams, you will lead strategy across key milestones-from expedited designations and Health Authority interactions through major submissions and post-approval maintenance-helping the business deliver transformative therapies at pace and with rigor. In this Director role, you will shape the regulatory path for programs that span oncology, immune-mediated and rare diseases-translating breakthrough science into timely approvals and competitive labeling that make a tangible difference to patients and markets.
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.
Director of Regulatory Affairs Blue Origin Enterprises LPDirector of Regulatory AffairsArlington, VAand/or transports placardable amounts of hazardous materials by ground in any vehicle on a public road while in commerce, may be subject to additional Federal Motor Carrier Safety Regulations including: Driver Qualification Files, Medical Certification (obtained before onboarding), Road Test, Hours of Service, Drug and Alcohol Testing (CDL drivers only), vehicle inspection requirements, CDL requirements (if applicable) and hazardous materials transportation/shipping training. Government Relations leadership includes directing senior-level relationships with lawmakers and executive agency staff, guiding advocacy strategy on Capitol Hill, overseeing policy-related projects, managing federal and state agency interactions, and providing strategic direction to external consultants and Blue Origin partners.
General Counsel & Head of Regulatory Affairs Quantic School of Business and TechnologyGeneral Counsel & Head of Regulatory AffairsWashington, DC$235,000–$285,000Higher-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.
Policy & Regulatory Affairs Manager Children's Hospital AssociationPolicy & Regulatory Affairs ManagerWashingtonThis position will manage significant health policy analysis for Children’s Hospital Association’s (CHA) advocacy work, including planning, organizing and providing policy analysis to influence the federal Administration on priority issues, and policy support for legislative advocacy, including the outlining of policy options and solutions to benefit children and children’s hospitals. Develop proactive advocacy strategies to advance CHA regulatory priorities in assigned issues; monitor, analyze, and respond to regulatory guidance and other administrative activities relevant to children’s hospitals and children’s health.