- BeOne Medicines (Emeryville, 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
- Lilly (San Francisco, CA)
- …are determined to make life better for people around the world. **Job Summary** The Director / Senior Director , CMC , Drug Product Development will lead ... capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and… more
- Sumitomo Pharma (Sacramento, CA)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Director , Global Regulatory Project Management ( Director , Global RPM) is a senior strategic leader responsible for ... submissions and ensuring seamless cross-functional integration across regions. The Director , Global RPM proactively anticipates regulatory challenges, influences… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and ... executing regulatory strategies across the global drug development lifecycle. This...senior stakeholders and cross-functional teams (clinical, medical, safety, CMC , commercial) across regions to achieve strategic business goals… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Director , Global Supplier Quality** Gilead Sciences, Inc. is a ... External Quality is currently seeking a leader at the Senior Director level to lead a team...Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC , and the Gilead Site Quality… 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
- AbbVie (Irvine, CA)
- …+ Author and review CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority inquiries. + Provide ... supports manufacturing, process transfer/optimization/characterization/validation, analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for late-stage and commercial… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** **Head of Technical Development Data & Digital Team ( Senior Director )** We are seeking a highly motivated individual to ... join the Technical Development Strategy and Operations team as ** Senior Director of Data & Digital Team**...and partner closely with Technical Development leadership, IT, Manufacturing, CMC Regulatory and the broader Gilead digital… more