- BeOne Medicines (Emeryville, CA)
- **General** **Description:** The Regulatory Affairs Director Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... native speaker is preferred + **Location:** US (remote). **Reports To:** Executive Director , Global Regulatory Strategy, Dx/CDx and Medical Devices. All… more
- GRAIL (Menlo Park, CA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- BeOne Medicines (San Carlos, CA)
- **General Description:** The Director , Global R&D Compliance will serve as the strategic compliance business partner and advisor to BeOne's Global Research & ... areas. Additionally, this role will support key functions with our Global Medical Affairs team. This individual will play a critical leadership role in sustaining… more
- BeOne Medicines (Emeryville, CA)
- …**Cross-Functional & External Engagement** + Serve as the analytical liaison across GCO, Regulatory , Medical Affairs , Access, and Corporate Affairs to ensure ... **General Description:** Reporting to the Head/ Director of Clinical Trial Diversity, the Associate Director will operationalize BeOne's clinical trial diversity… more
- Terumo Neuro (Aliso Viejo, CA)
- …priorities. + Act as a key liaison between Clinical Operations and departments such as Regulatory Affairs , Quality, R&D, PACE, R&D, and Medical Affairs to ... **13125BR** **Title:** Associate Director , Clinical Research (US Remote) **Job Description:** Lead...management, team leadership, and strong cross-functional collaboration with Medical Affairs , PACE, Regulatory , Clinical Safety, and Data… more
- BeOne Medicines (San Mateo, CA)
- …can be in drug development, clinical operations, clinical quality assurance, medical affairs , clinical regulatory compliance or a related field. **Other ... **General Description:** The Director , Global Clinical Operations, Compliance builds, collaborates and...strong aptitude to learn about the evolving legal and regulatory environment, ICH GCP, applicable laws, regulations, and industry… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Director , Strategic Evidence, will possess an understanding of US market access priorities, evidence generation, and proficiency in AI ... in collaboration with account teams and market access stakeholders (HEOR, medical affairs , fHEOR). This role is central in identifying appropriate RWD sources and… more
- BeOne Medicines (San Mateo, CA)
- …the Job:** + The individual should collaborate internally with Quality, Supply Chain, Regulatory Affairs and externally with CDMO to ensure timely and ... successfully project delivery at all stages. **Manage drug product technology transfer** + Coordinate with internal and external parties to establish tech transfer plan and project timeline + Lead the collaboration with all relevant functions to implement and… more
- Sumitomo Pharma (Sacramento, CA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory ... and registration strategies within the US and Canada. The Director will also provide line management, people development, and...candidates will have experience working as a lead in Regulatory Affairs with the FDA and prior… more
- Stryker (Sacramento, CA)
- The **Senior Director , Regulatory Affairs ** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and ... with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team will develop and advise on product positioning, product entry… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow and become your best self. Become a **maker of possible** with us. Director of Regulatory Affairs is responsible for developing and implementing ... Director , Regulatory Management, WW IPD ("Sr Director Regulatory WWIPD") and submissions, in support...with US and international laws and regulations + Manage Regulatory Affairs platform and leads a team… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …and become your best self. Become a **maker of possible** with us. **The Associate Director of Regulatory Affairs ** will provide regulatory support for ... regulatory strategies for new product submissions, project management for regulatory affairs submissions, handling existing product registrations including… more
- Gilead Sciences, Inc. (Foster City, CA)
- …directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16 years ... PhD, PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in… more
- Danaher Corporation (Sunnyvale, CA)
- …to complicated assay, instrument, software projects and/or system projects. This position reports to the Director Regulatory Affairs , NPD and is part of the ... Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Regulatory Affairs Principal is responsible for serving… more
- Liberty Utilities (Tahoe Vista, CA)
- …how we achieve it.** **Purpose** The Regulatory Analyst will report to the Director , Rates and Regulatory Affairs , and will undertake complex financial ... Analyst III, Rates and Regulatory Affairs LU Calpeco Electric LLC Tahoe Vista, CA, US, 96148 **Our purpose is sustaining energy and water for life, and it is… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …learn, grow, and become your best self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to the Senior Director ... Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of...product development, sustaining, and end of life activities. The Director will oversee the hiring, training, and career development… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- As a senior leader within Medical Affairs , the Executive Director will serve as a strategic thought partner and Chief of Staff to the Vice President of Medical ... capabilities aligned with Otsuka's vision, direction, and growth strategy. The Executive Director , Medical Affairs Strategy, Excellence & Operations will lead… more
- AbbVie (Irvine, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Medical Affairs (Facial Aesthetics Portfolio and Bodycontouring) ... Medical Affairs , in partnership with key Medical functional units, the Director , Medical Affairs will support development of a comprehensive medical strategy… more
- Gilead Sciences, Inc. (CA)
- …lead - Central US** We are looking for a highly motivated Medical Affairs Director who is passionate about patient-centric care related to pre-exposure ... have the following exciting opportunity as a remote position: ** Director , US Medical Affairs - HIV Prevention...**Cross-Functional Collaboration** + Work in partnership with the commercial, regulatory , and medical affairs teams to ensure… more
