- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications… more
- BeOne Medicines (Emeryville, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …You will also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible ... + Local Technical Services organizations + Global Quality and Regulatory CMC teams + Ensure process knowledge...and/or parenterals). + Demonstrated success as an SME and project leader in a matrix environment, influencing technical decisions… more
- BeOne Medicines (Emeryville, CA)
- …commercial negotiations, defining responsibilities between BeiGene and the CMO. Act as project manager of the contract negotiation with close partnership with ... **General Description:** The Senior Procurement Manager of CMO Category is responsible for establishing,...with contract manufacturers (CMOs) worldwide, Commercial Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC … more
- Amgen (Thousand Oaks, CA)
- …partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will ... improvements, and support method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ensuring… 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 ... The Senior Manager , Global Product Quality - Biologics is responsible...Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams… more
- Bristol Myers Squibb (San Diego, CA)
- …and mentor junior scientists and associates. + Documentation: Draft and review CMC sections for regulatory submissions, SOPs, and comprehensive development ... into robust clinical drug products. The Sr. Scientist will lead CMC radiopharmaceutical process development, oversee IND-enabling activities, and play a pivotal… more
- AbbVie (Irvine, CA)
- …(TPP), Asset Plan and PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. + Ensures ... brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Senior Director, Product Management Team Lead (Early Phase) will have experience serving as project manager for early phase biopharma molecules and will serve as ... **KEY RESPONSIBILITIES** Reporting to the Executive Director of Product & Project Management and operating within the broader Pharmaceutical Development and… more