- Gilead Sciences, Inc. (Foster City, CA)
- … Information Management system. **Qualifications** + Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs ( CMC RA) or other relevant ... guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs - Small Molecule Group. Responsibilities and qualifications are ... risk mitigation plans. Shadows leads while they develop and execute robust CMC regulatory strategies. + Under the guidance of more senior staff, oversees the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …degree with directly relevant professional experience in small molecule and biologics development, global CMC regulatory affairs and CMC technical areas ... with an MA/MS, PhD, PharmD, or MD. + Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies,… more
- BeOne Medicines (San Mateo, CA)
- …and mitigation plans, both internally and with external partners. + Collaborate with Regulatory Affairs , Clinical, CMC , Quality, Safety, and Commercial ... levels, including BeOne's Senior Management. This role blends deep expertise in regulatory affairs with best-in-class project management skills to ensure timely,… more
- Bristol Myers Squibb (San Diego, CA)
- …information. This role will work cross-functionally with several departments (Clinical Operations, CMC , Regulatory Affairs , Supply Chain, Drug Safety/PV, ... milestones, etc. are aligned to study specific timelines + Work with regulatory affairs to ensure that all investigator-initiated trials adhere to relevant … more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... analytical deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate… more
- Ascendis Pharma (Palo Alto, CA)
- …we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned ... devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in...on North and South America + Experience with biologics, CMC , Toxicology, Orphan Drugs development, breakthrough and fast track… more
- AbbVie (Irvine, CA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director, Regulatory Affairs Devices and Combination Products works with internal ... responsibilities. + Develops and implements policies and procedures within the regulatory affairs department. + Analyzes legislation, regulation, and guidance… 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
- AbbVie (San Francisco, CA)
- …of Drug Development (eg, pre-clinical research, clinical development, Regulatory Affairs , Chemistry Manufacturing and Controls ( CMC )). + Experience with ... conducting due diligence exercises within a scientific environment preferred. + Highly motivated professional with strong organizational and communication skills, excellent work ethic, and the ability to work independently as well as collaboratively in a team… more