- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …and maintain collaborative relationships with other local and/or global functional units [OPC CMC Global Regulatory Affairs , Global Regulatory ... **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing … more
- Parexel (Sacramento, CA)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… more
- Gilead Sciences, Inc. (Foster City, CA)
- …A scientific degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC ... Regulatory Excellence** Lead the development of global CMC regulatory initiatives focused...PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative… more
- Gilead Sciences, Inc. (Foster City, CA)
- …operating seamlessly connected with the broader enterprise. + Partner with Regulatory Affairs , Quality, Technical Development, and Manufacturing stakeholders to ... Experience in regulatory operations, strategic planning, and operational execution of CMC RA initiatives. + Experience with CMC requirements for drug… more
- Parexel (Sacramento, CA)
- …and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan ... CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as..., Project Management). + 3+ years proven experience in regulatory affairs , particularly in CMC … more
- Kelly Services (South San Francisco, CA)
- **Kelly(R) Science & Clinical** is seeking a Vice President/Senior Vice President, Global Regulatory Affairs for a direct-hire position at our late ... **The Experts at Hiring Experts.** **Title:** Vice President/Senior Vice President, Global Regulatory Affairs **Pay:** $300,000-$400,000 per year,… more
- Sumitomo Pharma (Sacramento, CA)
- …Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will ... of the product + Supports the global regulatory lead (GRL) and the CMC ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Parexel (Sacramento, CA)
- …EU, CH, DE, AU) and non-US/Central EU markets, ensuring compliance with global regulatory requirements and supporting cross-functional teams in delivering ... country-specific regulatory requirements. * Act as key partner to GRA Regions, Regulatory CMC and Supply Chain. Qualifications: * University degree in Life… 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