- Gilead Sciences, Inc. (Foster City, CA)
- …PDM functions including Product and Portfolio Strategy, Global Manufacturing,Supply Chain, Regulatory CMC , and the wider Quality organization to achieve ... procedures to ensure compliance withGxPstandards, corporate policies, FDA, EMA,and other regulatory body regulations and guidelines. + Set and drive compliance to… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …effectively with local Technical Services, site leadership, Pharmaceutical Sciences, Global Quality, Regulatory CMC , and other key functions to align on ... will be at the interface of development, manufacturing, and regulatory , shaping robust, scalable processes and ensuring they are...of drug product and packaging processes in line with regulatory and Takeda standards. + Act as part of… more
- BeOne Medicines (Emeryville, CA)
- …and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand ... protocol(s). + Coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations, CRO) and CMOs. + Support IRT user acceptance testing,… more
- BeOne Medicines (San Mateo, CA)
- …and provide a high service level to internal stakeholders (eg Clinical Operations, Regulatory , Quality, CMC ). + Work with Clinical Operations to understand ... + May coordinate review and approval of labels with stakeholders (eg Regulatory , Clinical Operations, CRO) and CMOs. + Support IRT user acceptance testing,… more
- Surrozen (South San Francisco, CA)
- …write detailed technical reports; and assist in developing workflows to support CMC , business development activities, and regulatory filings. . Collaborate ... anti-drug antibody (ADA) assays, and pharmacokinetic (PK), potency assays to support CMC activities, as well as analyzing study samples. The ideal candidate will… more
- Kelly Services (Irvine, CA)
- …provide day-to-day direction to junior chemists (4-5 team members). + Contribute to CMC documentation in support of regulatory filings (ANDA). + Perform other ... + Knowledge of **cGMP** , **USP** , and **FDA** regulatory requirements. + Experience preparing CMC documentation for ANDA filings preferred. + Proven ability to… more
- Kelly Services (South San Francisco, CA)
- …& Clinical** is seeking a Vice President/Senior Vice President, Global Regulatory Affairs for a direct-hire position at our late clinical-stage, innovation-driven ... Biotech client. If you're passionate about shaping regulatory strategy and compliance for breakthrough therapies-and are ready to make an impact in a high-growth… more
- Deloitte (San Diego, CA)
- …solutions + 4+ years of experience with Life Sciences Pharmaceutical R&D regulatory data lifecycle . Experience to include introducing new technologies like GenAI, ... immigration sponsorship may be available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and generating… more
- Kelly Services (South San Francisco, CA)
- …partners, and serving as the drug product/analytical lead across all CMC (Chemistry, Manufacturing, and Controls) teams. Additionally, this position will provide ... United States, reporting directly to the Senior Vice President, Head of CMC . **Responsibilities** + Provide strategic leadership for drug product development and… more