- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Responsibilities** + The Regulatory Affairs CMC Senior Manager at Gilead is responsible for ... + MD **Preferred Qualifications** + Has 5+ years of relevant experience in Regulatory Affairs CMC or other relevant industry experience with advanced degree.… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned ... drug manufacturing processes, GMP and related issues. + Knowledge of CMC regulatory requirements for biologics and small molecules during development and… more
- Vera Therapeutics (Brisbane, CA)
- …including Research, Clinical Pharm, Analytical Science, Drug product, Quality Assurance, Regulatory Affairs , Supply chain, Finance, and Program Management. Write ... Title: Senior Manager , Early-Stage Biologics Development, CMC Location:...teams. * Prepare, review, or edit cGMP batch records, CMC regulatory and quality documents. Qualifications: *… 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
- Vera Therapeutics (Brisbane, CA)
- …development programs. The Senior Manager will support both Clinical Regulatory and CMC activities. Responsibilities: * Proactively manage regulatory ... Title: Senior Manager , Clinical Regulatory Location: Brisbane, California...content that meets current regional requirements * Represent clinical Regulatory Affairs on cross-functional project teams *… more
- Sumitomo Pharma (Sacramento, CA)
- …to clinical supplies on multiple clinical programs. In addition, working closely with CMC , Regulatory Affairs , Quality Assurance, Clinical Operations, and ... motivated, and experienced individual for the position of **Senior Manager , Clinical Supply Chain** . The Senior Manager...and/or local regulations. + Collaborate closely with Clinical Operations, CMC , Regulatory Affairs , QA, and… more
- Amgen (Thousand Oaks, CA)
- …supply network and work with region's cross functional team (Commercial, Finance, Regulatory Affairs , Quality) to develop compliant product supply strategy for ... Life Cycle Management, Product Launches, Planning + Experience with Regulatory Affairs requirements, Clinical Development and/or International Business,… more