- 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
- 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
- Ascendis Pharma (Palo Alto, CA)
- …Today, we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the therapeutic area head for ... the US RA Strategy team. This role involves managing regulatory submissions and providing strategic leadership to ensure the...as well as Life Cycle Management Strategies. The Sr. Director will work closely with the executive team to… 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
- 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
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and drug ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Executive Director , Formulation and Process Development** + The Executive Director ... and understanding to support product robustness targets + Serve as a senior member of the Technical Development Leadership Team responsible for developing and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory , or process development, or as part of a cross-functional ... 35 countries worldwide, with headquarters in Foster City, California. **Executive Director , PDM Product Strategy Leader** **KEY RESPONSIBILITIES** Reporting to the… more