- Stryker (San Jose, CA)
- The **Senior Director , Regulatory Affairs** is a key strategist, responsible for developing regulatory strategy for the **Endoscopy business unit** and ... partnership with business unit leadership, Marketing, R&D, Clinical and Quality teams, the Senior Director and team...**Key Areas of Responsibility:** + Ensure divisional achievement of quality , regulatory , and compliance targets + Direct… more
- Chemours (Sacramento, CA)
- …and more modern living depend on Chemours chemistry. Chemours is seeking a ** Director of Regulatory Advocacy** to join our growing Government Affairs team! ... electronics, high-performance computing and AI, climate friendly cooling, and high- quality paints and coatings for homes and industrial infrastructure sustainable… more
- Gilead Sciences, Inc. (Foster City, CA)
- …life cycle management (IND, IMPD/CTA, NDA, MAA, etc.). + Deep understanding of global regulatory requirements and guidelines. + Ability to prioritize and manage ... be clear/specific regulatory guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs, and affiliates on… more
- GRAIL (Menlo Park, CA)
- … Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market ... to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory...**Experience** + Minimum of 8 years of experience in regulatory , development, clinical affairs, quality , or program… more
- BeOne Medicines (San Mateo, CA)
- …CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-approval applications. + ... **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director Global Clinical Compliance builds, collaborates and manages key relations to better support and understand the ... needs of the business and drive the compliance activities within Global Clinical Operations. Provides quality guidance, direction and expertise… more
- AbbVie (Irvine, CA)
- …committed to providing the most comprehensive science-based product offerings available. The Director (II) Product Development, Global Skincare R&D will be based ... in Irvine, CA., reporting to the VP of Global Skincare R&D. The Director (II) is...bring agility, innovation within the AbbVie operating model and quality systems. The individual will drive and manage all… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for all ... and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and… more
- Terumo Neuro (Aliso Viejo, CA)
- **12896BR** **Title:** Sr. Director , Global Social Responsibility **Job Description:** Responsible for leading and integrating global strategic initiatives ... risk management process for a medical device company. **External-Facing Title:** Sr Director , Global Social Responsibility **Posting Country:** US - United… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** Gilead's Director , Global Clinical Supply Chain is an end-to-end clinical supply ... that provides relevant expertise in a fast-paced biopharmaceutical environment. The Senior Director works internally with other members of Global Supply Chain… more