- Kelly Services (South San Francisco, CA)
- Kelly(R) Science & Clinical is seeking a CMC Project Manager for a one-year contract opportunity with a leading biopharmaceutical company in South San ... Hybrid, onsite in South San Francisco, CA **Position Title:** CMC Project Manager **Position Type:**...operational excellence. You'll work closely with cross-functional leaders across CMC , Drug Development, QA, Regulatory , and external… more
- BeOne Medicines (San Mateo, 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
- Actalent (Lake Forest, CA)
- Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities. This ... of global medical device regulations (eg, FDA CFR, EU MDR). Skills Regulatory , new product development, quality, risk mitigation, Project management,… 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
- 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
- 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
- Astrix Technology (San Diego, CA)
- …and day-to-day operations within the QC department + Report directly to the CMC Expert Manager **Qualifications:** + Master's degree in Chemistry (Bac+5); ... technical documentation + Perform analytical data review to ensure compliance with regulatory and quality standards + Manage and execute stability studies + Support… more