- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- BeOne Medicines (San Mateo, CA)
- …mitigation plans, both internally and with external partners. + Collaborate with Regulatory Affairs, Clinical, CMC , Quality, Safety, and Commercial functions to ... **General Description:** The Senior Director of Global Regulatory Project Management is a pivotal leadership role...responsible for overseeing and driving the successful execution of regulatory strategies and projects in a dynamic and highly… more
- Ascendis Pharma (Palo Alto, CA)
- …advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned products ... and lead the US RA Strategy team. This role involves managing regulatory submissions and providing strategic leadership to ensure the successful design and execution… more
- Deloitte (Los Angeles, CA)
- …experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and ... automation for pharmaceutical regulatory content or regulatory intelligence; Veeva RIM...generating submissions packages + Experience with submissions management, labeling, CMC change control and/or LCM processes + Understanding of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …into the clinic. The successful candidate is expected to serve as the CMC analytical lead on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he ... sit in our Foster City, CA headquarters. **Responsibilities:** + Lead CMC Analytical sub-team (as ASTL) to identify molecule CQAs, design/justify/execute end-to-end… more
- AbbVie (South San Francisco, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Biologics CMC Development team at AbbVie has a long and rich history of ... art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC … more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …analytical methods meet the highest industry standard + Draft and review of CMC sections and supporting documents for Regulatory filings. Participate in PAI, ... defend regulatory audits and draft responses + Responsible for personnel recruitment, development and retention + Ensure a collaborative work environment with key client groups in Research, Quality, Manufacturing and Process Development to support… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC , and the wider PDM Quality organization. The successful candidate must have ... and ensure visibility and communication of strategy, key project timelines and CMC milestones. + Monitor and review cross-functional process and product data to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance ... input + Hire, mentor and develop team members within the organization + Support regulatory filings by guiding the draft, review, and approval of CMC sections;… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …We are seeking a highly motivated individual with a background in CMC analytical control strategy and method lifecycle management experience of Advanced therapy ... who will work within cross functional groups with process development, quality, regulatory to lead the implementation of the analytical control strategy through the… more