- Parexel (Sacramento, CA)
- …innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager ** to join a growing, ... requirements. Project Management: Serve as the project manager for meetings, adhering to best...Project Management). + 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing,… more
- 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 (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
- Genentech (South San Francisco, CA)
- **The Position** **Technical Development Team Project Manager ** The Technical Development Team Project Manager (TDT PM) partners with a Technical ... **preferred.** Preferred Knowledge/Skills/Competencies + Understanding of the drug development and CMC process development. + Project management experience with… 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, 510(k), Project management, engineering, MDR,… 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
- 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
- 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