- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...throughout product life cycle. Escalate the critical issues to senior management timely. + Lead or contribute to development… more
- Gilead Sciences, Inc. (Foster City, CA)
- …on draft regulatory guidances, and communicates changes in regulatory CMC information to project teams and senior management. + Provides advice and ... with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Join Kite and help create more tomorrows. **Job Description** We are looking for a Sr Director , Analytical Operations to join our team at our Kite headquarters ... the highest industry standard + Draft and review of CMC sections and supporting documents for Regulatory ...ability to work with both subordinate staff and corporate senior leadership team + Excellent interpersonal, verbal and written… more
- Ascendis Pharma (Palo Alto, CA)
- …United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr . Director , Regulatory Affairs will serve as the therapeutic ... the US RA Strategy team. This role involves managing regulatory submissions and providing strategic leadership to ensure the...trials as well as Life Cycle Management Strategies. The Sr . Director will work closely with the… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Senior Director of Global Regulatory Project Management is a pivotal leadership role responsible for overseeing and driving the ... BeOne's Senior Management. This role blends deep expertise in regulatory affairs with best-in-class project management skills to ensure timely, compliant, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. ** Senior Director ,** **Product Management** **Team** **Lead** **(Early Phase)** ... operating within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director , Product Management Team Lead** will lead a… more
- BeOne Medicines (Emeryville, CA)
- **_General Description:_** Sr . Manager/Associate Director , Supply Chain CMO Management & PM will own and enable the communication, coordinate tasks between the ... production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new market launch… more
- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations and emerging issues.… more
- Vera Therapeutics (Brisbane, CA)
- …Summary: The Senior Manager, Manufacturing, Drug Product will report to the Senior Director , Manufacturing and will be responsible for all aspects of Drug ... Title: Senior Manager, Manufacturing, Drug Product Location: Brisbane, California...capabilities. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. * Participate… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …development workflows, and ensure viral safety strategies are aligned with global regulatory expectations. The Director will operate strategically in a highly ... collaborative environment, partnering closely with Research, Analytics, CMC , Regulatory , Commercial Manufacturing, Quality, and external partners. In addition,… more