- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Job Summary** The Chemistry, Manufacturing and Controls ( CMC ) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global ... regulatory strategies for CMC aspects of small molecule products during late-stage development and throughout the commercial lifecycle. This includes initial… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Building** + Develop a roadmap that fosters innovation to assist where and when CMC RA invest resources and budget. + Own continuous improvement of the operating ... model and capability roadmap for the CMC RA function. + Creating and implementing functional business...strategic initiatives, centralize activities, and foster cross-functional support of CMC RA's processes, systems, data, and tools. + Define… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics....the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD … more
- Parexel (Sacramento, CA)
- …highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's ... timely approvals and supporting continued market access. Key Responsibilities Strategic CMC Leadership * Provide regulatory strategy input for small molecules… more
- Parexel (Sacramento, CA)
- …to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager** to join a growing, dedicated client partnership and play ... department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …not limited to the following:** A summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, ... The summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed applications in line with regulatory… more
- Lilly (San Francisco, CA)
- …for people around the world. **Job Summary** The Director/Senior Director, CMC , Drug Product Development will lead formulation development activities across multiple ... CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development… more
- AbbVie (South San Francisco, CA)
- …in the pharmaceutical industry. This is a reality for AbbVie Interns. The CMC Biologics Drug Substance organization is a team of scientists driving scientific ... solutions. They are responsible for all Chemistry, Manufacturing, and Control ( CMC ) cell line and bioprocess development activities for AbbVie's early-stage and… more
- LGC Group (Petaluma, CA)
- …Axolabs is a business unit of LGC, and a leading provider of CRO / CDMO capability to the therapeutic oligonucleotide discovery and development industry. Centred out ... of LGC's site in Kulmbach, Germany, Axolabs works closely with its customers to assist the identification and development of lead candidates with a broad suite of bioinformatics, biology, chemistry, manufacturing and analytical services that support discovery,… more
- Hyundai Autoever America (Costa Mesa, CA)
- …is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, ... responsibilities, and activities may change at any time with or without notice. Basic Requirements: + Bachelor's Degree or higher in a related field + 5 + years of experience in a similar role such as client relationship/ key account management, preferably in… more