- BeOne Medicines (Emeryville, CA)
- …currently have an exciting opportunity available for an experienced Senior Director , Investigator-Initiated Trials (IIT) and Expanded Access Programs in Global ... and non-medical functions (eg, Marketing, Market Access, HEOR, Legal, Compliance, Regulatory , etc.). This position will also assist with program management,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …**Job Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal and Commercial ... deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate across Gilead… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …skilled and experienced professional to join our organization as the Assoc. Director of Manufacturing Science and Technology (MSAT) for Upstream processes. This ... and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. +… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Position Overview:** The Senior Director , MSAT Biologics provides strategic and technical leadership for all late-stage and commercial manufacturing processes for ... process validation lifecycle (PPQ, CPV, etc.) ensuring compliance with global regulatory standards. + Establish and oversee robust Continued Process Verification… more
- Bristol Myers Squibb (San Diego, CA)
- …to be the global leader in radiopharmaceuticals . The Senior Medical Director - Clinical Development (GU Cancer/Prostate Renal) has responsibility for the clinical ... development plans in GU cancers. Responsibilities include support for IND preparation, regulatory authority interactions, design and execution of Phase 1 to Phase 3… more
- Imperative Care (Campbell, CA)
- Title: Director , Design Assurance This position is based in our Campbell, California offices. This position is on-site, full-time. Why Imperative Care? Do you want ... the design assurance team and ensure compliance with domestic and international regulatory standards (eg, FDA, CE marking, etc.). + Build and sustain relationships… more
- Amazon (Sunnyvale, CA)
- …ensure our systems are secure by default and delightful for customers. As the Director of Kuiper Security Assurance, you will manage a team of compliance subject ... bar for Project Kuiper. You will maintain customer and regulatory relationships, identify applicable industry requirements, and establish long-term strategies… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** **KEY RESPONSIBILITIES** Director , Global External Manufacturing Oral-Solid Dosage (OSD) leads a team ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Sr. Director Commercial Planning Supply Chain, Foster City, CA** **Knowledge:** + Able ... in depth knowledge of industry practices. + Solid working knowledge of relevant regulatory guidance, including pharmaceutical GMPs and ICH Q7A. + Able to apply… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …responsible for 1) the creation and management of communications with FDA and other regulatory agencies, 2) ensuring that commitments made to the FDA and other ... regulatory agencies (eg, recall letters) are implemented at the...areas within the business unit with expectations from external regulatory contacts. Activities include: + Facilitates the collection of… more