- Gilead Sciences, Inc. (Foster City, CA)
- …Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC requirements for drug ... Building** + Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. + Own continuous improvement of the operating… more
- Lilly (San Francisco, CA)
- …(CROs, CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product ... for people around the world. **Job Summary** The Director/Senior Director, CMC , Drug Product Development will lead formulation development activities across multiple… 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
- 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 ... highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global … 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 ... analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate… 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
- Genentech (South San Francisco, CA)
- …drug product, analytical development & quality control, device and delivery, regulatory CMC , manufacturing sciences, and clinical and commercial manufacturing ... and regulatory expectations. Additionally, you will oversee portfolio execution, CMC project management, and a team of technical development leaders ( CMC… more
- Parexel (Sacramento, CA)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate, timely,… more
- ThermoFisher Scientific (San Diego, CA)
- …and batch records + Collaborates with multiple functional lines (Pre-clinical, Clinical, CMC , Regulatory , Quality Assurance, Commercial) within the company + ... necessary to develop and manufacture API + Familiarity with regulatory and quality aspects of CMC and API activities and documentation + Ability to think… more
- Genentech (South San Francisco, CA)
- …understanding of PM practices, business processes and tools; relevant process validation, ** CMC ** functions, regulatory , quality and cGMP experience preferred. + ... (TDL) to manage technical development team(s) in defining and implementing CMC strategies and activities associated with developing clinical candidates from… more