Director of Regulatory Affairs and Policy SupplyBank.orgDirector of Regulatory Affairs and PolicyOakland, CA$115,000–$130,000 / yearThrough partnerships with global supply chains and community organizations, SupplyBank.org provides a highly cost-effective and scalable mechanism for bulk purchasing and efficiently distributing necessary health, education, and emergency supplies to children, families, and communities that need them throughout California. Of the total 100 acres, more than 80 will be revitalized park spaces, infrastructure improvements and nature based solutions to restore tidal wetlands, habitat, flood management and increase public enjoyment of the Bay Trail and parklands.
Director of Regulatory Affairs Radiant Industries IncDirector of Regulatory AffairsEl Segundo, CACraft a modern regulatory strategy based in sound engineering principles with input from executives, our board of directors, and industry experts that brings the safest product to market the fastest. Portable nuclear power with rapid-deploy capability can replace similar-sized diesel generators and provide critical asset support for hospitals, data centers, remote sites, and military bases.
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..
Executive Director of Regulatory Affairs - Obesity and Related Conditions Amgen IncExecutive Director of Regulatory Affairs - Obesity and Related ConditionsThousand Oaks, CA$255,302–$345,408 / yearIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Director of Regulatory Affairs Epia NeuroDirector of Regulatory AffairsAlameda, CaliforniaAs a Director of Regulatory Affairs you will report to the Chief Executive Officer and be responsible for owning the regulatory strategy and execution end-to-end from early FDA engagement through IDEs and PMA submission and approval, and commercialization. We’re looking for a Director of Regulatory Affairs for our office in Alameda, California who wants to lead, develop and execute the regulatory strategy for Epia Neuro’s Class III implantable neurotechnology.
Director of Regulatory Affairs and Quality Assurance (RA / QA) Eight SleepDirector of Regulatory Affairs and Quality Assurance (RA / QA)San Francisco, CaliforniaEvery role at Eight Sleep is a chance to create cutting-edge technology, collaborate with world-class talent, and help shape a future where sleep isn't passive, it's a powerful tool for living better. This role will provide leadership for risk management and oversee the operation of the quality management system, as well as serve as the primary interface between our company and regulatory agencies.
Director of Regulatory Affairs Radiant IndustriesDirector of Regulatory AffairsWashingtonCraft a modern regulatory strategy based in sound engineering principles with input from executives, our board of directors, and industry experts that brings the safest product to market the fastest. . Portable nuclear power with rapid-deploy capability can replace similar-sized diesel generators and provide critical asset support for hospitals, data centers, remote sites, and military bases.
Director / Senior Director of Regulatory Affairs PathosDirector / Senior Director of Regulatory AffairsNew YorkDirect IND lifecycle management experience: you have owned INDs from filing through amendment cycles, authored DSURs, prepared IB updates, and built FDA meeting packages as the primary author. That means authoring DSURs, preparing IB updates and IND amendments, building FDA meeting packages, managing ClinicalTrials.gov listings, and overseeing eCTD publishing.
Director of Regulatory Affairs and Quality Assurance (RA / QA) Eight Sleep IncDirector of Regulatory Affairs and Quality Assurance (RA / QA)San Francisco, CAEvery role at Eight Sleep is a chance to create cutting-edge technology, collaborate with world-class talent, and help shape a future where sleep isnt passive, its a powerful tool for living better. This role will provide leadership for risk management and oversee the operation of the quality management system, as well as serve as the primary interface between our company and regulatory agencies.
Sr Director of Regulatory Affairs - North America Perrigo Co PlcSr Director of Regulatory Affairs - North AmericaMorristown, NJ$225,000–$275,000 / yearLCM & Regulatory Operations owns regulatory classification governance, post-launch lifecycle activities (non-innovation), and operational processes and systems; this role sets market priorities and delivery expectations. Category Regulatory Affairs owns ideation-to-launch strategy, regulatory pathways, and global dossier expectations; this role provides market input and executes the agreed strategy locally.
Director of Regulatory Affairs SNF Holding CompanyDirector of Regulatory AffairsRiceboro, GeorgiaFull timeThe ideal candidate is a strategic thinker and people leader with deep regulatory expertise, strong cross-functional influence, and a proven ability to anticipate regulatory risk while supporting business growth. Overview: SNF is a specialty chemical group whose products, water-soluble polymers, contribute to treating, recycling, preserving water, saving energy, and reducing carbon footprint.
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.
NewDirector of Regulatory Affairs Zbiotics CompanyDirector of Regulatory Affairs$210,000–$240,000 / yearYou will advise on product classification, GRAS and NDI strategy, claims, labeling, studies, launches, and market access; lead substantive engagement with regulators; monitor and respond to emerging federal, state, and international requirements; and coordinate the internal and external experts needed to execute. Deep knowledge of U.S. FDA frameworks for foods, food ingredients, and dietary supplements, including meaningful experience with GRAS and related safety and submission strategies.
NewDirector of Regulatory Affairs VieMed Clinical Services LLCDirector of Regulatory AffairsLafayette, LAPart timeThese recordings may be reviewed by authorized company personnel and may be processed using artificial intelligence or automated tools to assist with notetaking, transcription, scheduling, candidate evaluation support, and other recruiting functions. By submitting your application and participating in the interview process, you acknowledge and consent that interviews, video meetings, phone screenings, and other recruiting interactions may be recorded for evaluation, training, quality assurance, compliance, and hiring purposes.
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 of Regulatory Affairs - NORAM/OCEANIA Monster EnergyDirector of Regulatory Affairs - NORAM/OCEANIALead regulatory deliverables in Stages 1-3, partnering with Project Managers on timelines and managing the resourcing of the assigned region regulatory team by monitoring workloads to ensure the team can adhere to timing of project deliverables. Responsible for developing and ensuring accurate and compliant label information, reviewing formulas for compliance, and supporting regulatory related product inquiries.
NewDirector of Regulatory Affairs VieMed CareersDirector of Regulatory AffairsLafayette, LouisianaThese recordings may be reviewed by authorized company personnel and may be processed using artificial intelligence or automated tools to assist with notetaking, transcription, scheduling, candidate evaluation support, and other recruiting functions. By submitting your application and participating in the interview process, you acknowledge and consent that interviews, video meetings, phone screenings, and other recruiting interactions may be recorded for evaluation, training, quality assurance, compliance, and hiring purposes.
Director of Quality and Regulatory Affairs MRINetwork JobsDirector of Quality and Regulatory AffairsDenver, ColoradoDirect experience in and knowledge of business and management principles involved in tactical execution, strategic planning, resource allocation, human resources modeling, leadership techniques, production methods, and coordination of people and resources. As Director of Regulatory Affairs – Compliance Systems and Labeling, you’ll direct regulatory and labeling activities and collaborate with senior teams to define strategy and compliance programs.
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.
Director of Regulatory Affairs Avalo TherapeuticsDirector of Regulatory AffairsPhiladelphia, PAThe Director will serve as a key member of cross-functional development teams, providing regulatory leadership across clinical development, regulatory submissions, health authority interactions, and lifecycle management activities. Avalo Therapeutics is seeking a strategic and execution-focused Director, Regulatory Affairs, to provide global regulatory leadership for abdakibart (AVTX-009), the company's lead asset, as it advances into Phase 3, and potential registration.
Director of Regulatory Affairs and Communication Contra Costa CountyCADirector of Regulatory Affairs and CommunicationMartinez, CA$147,558.98–$179,358.86 / yearThe Director of Regulatory Affairs and Communication (RAC) at Contract Costa Health Plan (CCHP or "Plan") is a senior leadership role responsible for leading regulatory oversight, agency communications, Policy Management Program, regulatory audit support, and enterprise regulatory strategy. This role serves as the primary liaison with state and federal regulators, including the California Department of Health Care Services (DHCS), Department of Managed Health Care (DMHC), and Centers for Medicare & Medicaid Services (CMS).
NewDirector of Regulatory Affairs Viemed Healthcare IncDirector of Regulatory AffairsLafayette, LAThese recordings may be reviewed by authorized company personnel and may be processed using artificial intelligence or automated tools to assist with notetaking, transcription, scheduling, candidate evaluation support, and other recruiting functions. By submitting your application and participating in the interview process, you acknowledge and consent that interviews, video meetings, phone screenings, and other recruiting interactions may be recorded for evaluation, training, quality assurance, compliance, and hiring purposes.
Director of Regulatory Affairs, Regulatory Affairs, Full Time Jackson Health SystemDirector of Regulatory Affairs, Regulatory Affairs, Full TimeMiami, FLIf you provide content to customers through CloudFront you can find steps to troubleshoot and help prevent this error by reviewing the CloudFront documentation. Generated by cloudfront CloudFrontRequest ID sdcR0SkKfNgkRKQt82WZvcl8Cvsaftd7q_KtgtY_Y6FMu2RcuoTZzg.
Director of Regulatory Affairs US FinTech | Supervisory & Licensing Governance MastarRecDirector of Regulatory Affairs US FinTech | Supervisory & Licensing GovernanceBleiblerville, TexasLeads engagement with federal and state regulators, manages licensing requirements, and oversees regulatory change management. • Multi-jurisdiction financial services exposure.
Chief of Staff, Senior Director Global Regulatory Affairs AstraZeneca PlcChief of Staff, Senior Director Global Regulatory AffairsBoston, MA$218,058.40–$327,087 / yearOrganizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.
Director of Quality Assurance & Regulatory Affairs Leslie's Poolmart IncDirector of Quality Assurance & Regulatory AffairsEast Saint Louis, ILWorking cross-functionally with Production, Supply Chain, Procurement, Sales, R&D, and Executive Leadership, the Director oversees quality systems, regulatory strategy, laboratory operations, audits, customer quality, and risk management to support business growth and product integrity. Job Overview: The Director of Quality Assurance & Regulatory Affairs provides strategic leadership for Stellar Manufacturings quality management systems, regulatory compliance, and product stewardship programs.
Chief of Staff, Senior Director Global Regulatory Affairs AlexionChief of Staff, Senior Director Global Regulatory AffairsBoston, MassachusettsOrganizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.
Senior Director, Head of Regulatory Affairs and Quality Satsuma PharmaceuticalsSenior Director, Head of Regulatory Affairs and QualityProvide leadership and oversight of the Quality Assurance function, including contract manufacturers and suppliers, product disposition and release, deviations, corrective and preventative actions, change control, complaints, annual product quality reviews, document control, training, audits, and inspection readiness. This role is responsible for directing interactions with the FDA, maintaining company-wide compliance with applicable regulatory and quality requirements, and partnering cross-functionally to ensure successful product launch and ongoing commercial support.
Chief of Staff, Senior Director Global Regulatory Affairs Alexion Pharmaceuticals IncChief of Staff, Senior Director Global Regulatory AffairsBoston, MA$218,058.40–$327,087 / yearOrganizational Effectiveness and Change: Support organization design, capability building, and talent initiatives; lead change programs and improvements in ways of working that increase clarity, speed, and accountability across the regulatory organization. Cross-Functional and Enterprise Coordination: Partner across R&D, Commercial, Safety, Medical, Legal, Finance, and Procurement to align competing priorities; coordinate across programs, therapy areas, and regions to resolve complex issues that impact filing readiness and approvals.
Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, IncDirector, Regulatory Affairs – Global Regulatory StrategyBoston, MassachusettsFull timeOverview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
Director of Policy and Regulatory Affairs XYPNDirector of Policy and Regulatory AffairsRemoteYou’ll work closely with our Managing Director of Compliance and Regulatory Affairs to shape and execute XYPN’s advocacy roadmap, leading efforts to monitor State & federal regulatory developments, develop policy positions, build relationships with regulators, and advance strategic engagement on issues impacting members. With a network of more than 2,200 fee-only financial planners and experience registering more than 2,000 investment advisers nationwide, we support firms across all 50 states and the SEC, giving us unique insight into the regulatory and operational challenges faced by independent RIAs operating across multiple jurisdictions.
Director of Licensing & Regulatory Affairs (SMR / MMR Programs) BaRupOn LLCDirector of Licensing & Regulatory Affairs (SMR / MMR Programs)Irvine, CABaRupOn LLC is seeking a highly experienced Director of Licensing & Regulatory Affairs to lead all regulatory strategy, licensing execution, and compliance activities for its Small Modular Reactor (SMR) and Micro Modular Reactor (MMR) programs in the United States. The ideal candidate brings deep, direct NRC engagement experience, a thorough command of U.S. nuclear regulatory frameworks, and the leadership ability to build and manage a high-performing regulatory team in a fast-moving, mission-driven environment.
Director, Regulatory Affairs Grid UnitedDirector, Regulatory AffairsEstablished in 2021 by proven industry leaders, Grid United is developing utility-scale, multi-state electric transmission projects that will provide long-term economic benefits to communities across the country, provide Americans with improved grid resiliency for our homes and businesses, and cost savings for electricity consumers. The Director of Regulatory Affairs will work cross-functionally with a growing team of talented experts as they collaborate closely with project partners to develop frameworks and build broad coalitions to effectuate the timely advancement of market structures that recognize and appropriately assign the value unlocked by interregional transmission.
Director of Individual Insurance Compliance & Regulatory Affairs Alera GroupDirector of Individual Insurance Compliance & Regulatory AffairsChicago, IllinoisReporting directly to the Chief Legal Officer with a dotted-line partnership to the SVP of Strategy & Operations, this role will collaborate across Legal, Operations, Marketing, IT, Carrier Relations, and agency leadership to drive consistency, accountability, and audit readiness throughout the organization. This senior leadership role is responsible for building scalable, defensible compliance frameworks that support growth while ensuring regulatory excellence across Medicare, ACA, and ancillary insurance products.
Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy Eli Lilly and CoSenior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory StrategyIndianapolis, IN$169,500–$248,600 / yearOur current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL). Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.
Executive Director, Regulatory Affairs – Global Regulatory Leader Summit TherapeuticsExecutive Director, Regulatory Affairs – Global Regulatory LeaderThe Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area. HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
Executive Director, Regulatory Affairs - Global Regulatory Leader Summit Therapeutics IncExecutive Director, Regulatory Affairs - Global Regulatory LeaderNY$231,000–$285,000 / yearOverview of Role: The Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area. HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
Regulatory Affairs Senior Director, Digitalization Becton Dickinson Medical DevicesRegulatory Affairs Senior Director, DigitalizationThe Senior Director of Regulatory Affairs, Digitalization, reports to the Vice President of Regulatory Affairs, Regulatory Affairs Management, Enterprise Excellence, and is responsible for establishing, executing, and maintaining the central regulatory affairs strategy for digital tools and systems required for regulatory activities and work across BUs and Regions. Lead Strategic Initiative Development : Identify, prioritize, and formalize global RA programs in partnership with the Senior Regulatory Leadership team, by analyzing internal performance data, external benchmarks, emerging digital, technical, and assessing impact, value and alignment with Global Regulatory Strategy.
Associate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion) Arrowhead PharmaceuticalsAssociate Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)Los Angeles, CA$180,000–$200,000 / yearProvide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels, including digital, social media, websites, emails, print, speaker programs, video testimonials, scientific congresses, and field communications, among others. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Director, Regulatory Affairs, Ex-US Larimar Therapeutics IncDirector, Regulatory Affairs, Ex-USPAProvide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements • Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan • Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions • Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings • Develop internal regulatory procedures and practices • Work closely with RA Sr. Requirements: Key Experience, Skills and Knowledge: • Minimum of 4-year undergraduate degree • 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred • Understanding of GxP systems and Quality principles • Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies • Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications • Excellent communication, time management and project management skills • Continuous quality improvement mindset and attention to details • Can do attitude, flexibility, and mental agility.
Director, Regulatory Affairs Mapp BiopharmaceuticalDirector, Regulatory AffairsSan Diego, CARemote$130,000–$250,000 / yearDirector, Regulatory Affairs FULLY REMOTE Assignment through Temporary Agency - Approximately 6 Months Approximately 40 Hours Per Week Job #26-01AT / #26-01A Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs. The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.
Regulatory Affairs Senior Director, Project Management Excellence Becton Dickinson Medical DevicesRegulatory Affairs Senior Director, Project Management ExcellenceProblem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions. Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.
Regulatory Affairs Senior Director, Digitalization Becton Dickinson and CoRegulatory Affairs Senior Director, DigitalizationFranklin Lakes, NJ$230,300–$368,500 / yearThe Senior Director of Regulatory Affairs, Digitalization, reports to the Vice President of Regulatory Affairs, Regulatory Affairs Management, Enterprise Excellence, and is responsible for establishing, executing, and maintaining the central regulatory affairs strategy for digital tools and systems required for regulatory activities and work across BUs and Regions. Lead Strategic Initiative Development: Identify, prioritize, and formalize global RA programs in partnership with the Senior Regulatory Leadership team, by analyzing internal performance data, external benchmarks, emerging digital, technical, and assessing impact, value and alignment with Global Regulatory Strategy.
Senior Director, Regulatory Affairs Bicara Therapeutics IncSenior Director, Regulatory AffairsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-\u03b2-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-\u03b2 ligand trap.
Associate Director Regulatory Affairs Alnylam Pharmaceuticals IncAssociate Director Regulatory AffairsCambridge, MA$170,900–$231,300 / yearAdditional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on US regulatory requirements, and interpreting regulatory intelligence for the internal teams. Serve as member of/or lead the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.
Associate Director, Regulatory Affairs Global Regulatory Advertising and Promotion Arrowhead Pharmaceuticals IncAssociate Director, Regulatory Affairs Global Regulatory Advertising and PromotionPasadena, CA$180,000–$200,000 / yearProvide regulatory review and strategic guidance for promotional (branded and disease state) and medical communications for US prescription drug products across multiple channels, including digital, social media, websites, emails, print, speaker programs, video testimonials, scientific congresses, and field communications, among others. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Regulatory Affairs Senior Director, Project Management Excellence Becton Dickinson and CoRegulatory Affairs Senior Director, Project Management ExcellenceFranklin Lakes, NJ$230,300–$368,500 / yearKnowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs. Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions.
Director/Senior Director, Regulatory Affairs SepternaDirector/Senior Director, Regulatory AffairsSouth San Francisco, CA$235,000–$285,000 / yearSepterna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission.
Director, Regulatory Affairs Recursion Pharmaceuticals IncDirector, Regulatory AffairsNew York, NYRemote$228,250–$280,720 / yearCreate and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter - faster, better, and at scale - for patients who are waiting.