- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …discipline. + RAC certification will be a plus. **Experience** : + 7+ years in Regulatory Affairs CMC , with significant experience in small molecules is ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing… more
- Parexel (Sacramento, CA)
- …treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager ** to join a growing, dedicated ... regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting..., Project Management). + 3+ years proven experience in regulatory affairs , particularly in CMC … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Parexel (Sacramento, CA)
- …country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life ... Join us as a **Global Labeling Operations Manager ** , where you'll work alongside a large,...AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering accurate,… more
- Actalent (Lake Forest, CA)
- Description We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities. ... Test plan, Regulatory compliance, Compliance, Quality engineering, Medical device, Regulatory affairs , CMC , manufacturing controls, RAC certification, e… more
- AbbVie (Irvine, CA)
- …brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs , etc., and ... Asset Plan and PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. + Ensures that the AST… more