- Gilead Sciences, Inc. (Foster City, CA)
- …+ A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and CMC ... serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics...+ Lead the execution and influence the development of global CMC regulatory strategies, including… 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)
- … regulatory guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal ... + Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs ( CMC...+ A proven track record of developing and leading global CMC regulatory submissions strategies… 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
- Ascendis Pharma (Palo Alto, CA)
- …Members, Product Management, and Leadership teams to develop and implement the US and global regulatory affairs plan across products + Oversee development ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe,...in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic… 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
- 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, ... shipments, milestones, etc. are aligned to study specific timelines + Work with regulatory affairs to ensure that all investigator-initiated trials adhere to… 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 ... **General Description:** The Senior Director of Global Regulatory Project Management is a...BeOne's Senior Management. This role blends deep expertise in regulatory affairs with best-in-class project management skills… more
- Cardinal Health (Sacramento, CA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... approvals. More specifically, this role serves the function to support global , post-approval lifecycle regulatory requirements for Biologics and small-chemical… more
- Cytel (Sacramento, CA)
- …with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs , to develop and implement appropriate statistical ... Bayesian analysis experience and had exposure to Chemistry, Manufacturing, and Controls ( CMC ) data analysis. You are excited and enthusiastic, motivate your teams to… more