- West Pharmaceutical Services (Exton, PA)
- Senior Regulatory Affairs Specialist Requisition ID: 71673 Date: Nov 4, 2025 Location: Exton, PA, US Department: Regulatory Affairs Description: **This ... and planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs , Medical is responsible for influencing department … more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- …on implantable and absorbable devices. Under the mentorship of the Manager of Regulatory Affairs , the position will provide technical and administrative ... with appropriate level of experience. + Minimum 1-2 years Regulatory Affairs experience in medical device or...regulations, 21 CFR 820 Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards,… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and services in more than 110 countries and regions. **Summary:** The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary ... to or including the US Food and Drug Administration ( FDA ), Clinical Laboratory Improvement Amendments (CLIA), Plasma...activities, as required. + Must be able to perform Regulatory Affairs Specialist role. + May review… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... following:** + Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of… more
- Stryker (Tempe, AZ)
- The **Director, Regulatory Affairs ** is a key strategist, responsible for developing and executing the global regulatory strategy for **Stryker ... practices and policy + Provides strategic input on regulatory requirements to R&D and clinical leads...Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …staff, grantees, and other foundation operational resources. + Experience in health product regulatory affairs , from research and clinical development to ... mindset and is recognized as a trusted partner and subject matter expert in regulatory affairs . Your expertise spans global regulatory filing strategies, WHO… more
- Taiho Oncology (Princeton, NJ)
- …records. The incumbent in this position may be required to perform other duties, as assigned. Job Details Job Family R&D Job Function Regulatory Affairs ... commercial support. + Knowledge of and experience interacting and negotiating with regulatory agencies, particularly the FDA . + Experience in biologics and/or… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Gilead Sciences, Inc. (Washington, DC)
- …directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years ... an MA/MS, PhD, PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership… more
- BD (Becton, Dickinson and Company) (Louisville, CO)
- **Job Description Summary** The Regulatory Affairs Specialist II is responsible for implementation of strategies including domestic and international submissions ... Must be able to maintain confidentiality in dealing with regulatory and clinical documentation **EDUCATION and/or EXPERIENCE**...with software and capital systems is a plus. + Regulatory Affairs Certification (RAC) desired At… more