- 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)
- …and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible ... of an approved/ harmonized regulatory control strategy. + Partner across CMC Regulatory Affairs , PDM, and other functional groups across Gilead. + Lead… 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
- 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
- Cardinal Health (Sacramento, CA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... submissions within the discipline of chemistry, manufacturing, and controls ( CMC ). The _Sr. Coordinator, Regulatory Submissions Operations_ will use… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more