- 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. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with life-threatening illnesses worldwide. **Responsibilities** + Responsible for leading all CMC regulatory activities for assigned project(s), in line with ... knowledge, and company policies and procedures. + Develops and implement CMC regulatory strategies, guiding teams across product lifecycle stages. + Actively… more
- AbbVie (Irvine, CA)
- …. Job Description Further develop your expertise and join our team as Director , CMC Product Development. Must have Medical Device experience. The Product ... Development Director (PDD) will be a member of the Operations...for launch. They are responsible for communicating development and regulatory risks and seeking feedback from CMC … more
- Gilead Sciences, Inc. (Foster City, CA)
- …devices. . **Global Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused on combination products and devices. Ensure ... directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas of at least 16… 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
- AbbVie (Irvine, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Regulatory Affairs Devices and Combination Products works with ... input into the preparation and maintenance of chemistry, manufacturing, and controls ( CMC ) device sections of regulatory submissions, responses to Agency… 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 ... both internally and with external partners. + Collaborate with Regulatory Affairs, Clinical, CMC , Quality, Safety, and Commercial functions to shape and execute… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ... Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal...deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… more
- BeOne Medicines (Emeryville, CA)
- …cost-effective production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new ... in a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements **Computer Skills**… 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