- 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 ... regulatory guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs,...across the global CMC RA organization, Gilead Regulatory Affairs, and affiliates on internal meetings and leads… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …for those with CNS disorders, we are seeking a skilled and experienced Medical Director of CNS Early Assets, Global Medical Affairs, responsible for certain ... Franchise Lead CNS Early Assets. **Position Summary:** The Medical Director , Global Medical Affairs, CNS Early Assets... global value and real-world evidence, US and global commercial teams, market access, and regulatory … more
- GRAIL (Menlo Park, CA)
- … plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing ... North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information,… more
- BeOne Medicines (San Mateo, CA)
- **_General Description:_** BeOne is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent ... responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the aggressive timelines… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for ... leading a global team focused on R&D Quality. This ...submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader… 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
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director Global Clinical Compliance builds, collaborates and manages key relations to better support and understand the ... of GMP and GDP compliance matters. This role reports to the Senior Director , Global Clinical Operations Compliance Lead. **Essential Functions of the Job:**… more
- Abbott (Alameda, CA)
- …our global IT and Business strategies. Reporting directly to the Global Commercial IT Director , your responsibilities will include collaborating with ... Analytics. **Strategic Alignment:** + Understand executive priorities by regularly engaging with the Global Commercial Director and Divisional VP of ADC IT to… 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...with other skincare R&D functions- skincare biological research, clinical, regulatory , safety and scientific affairs to create future pipeline… more