- Gilead Sciences, Inc. (Foster City, CA)
- …and inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics ... 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)
- … 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)
- …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
- 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, ... to be the global leader in radiopharmaceuticals . The Director , Medical Affairs Research Operations, plays an...are aligned to study specific timelines + Work with regulatory affairs to ensure that all investigator-initiated… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... Description:** **We are seeking a talented and highly motivated Director for our Structural Characterization team in Biologics Pivotal...deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support… 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 ... **Associate Director , Small Molecule Analytical Development** + Lead and...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
- BeOne Medicines (Emeryville, CA)
- …**job:** Accountable and responsible for building and maintaining relationships within Regulatory Affairs and functional organizations including partnering with ... as CMC , Reg Strategy, Clinical/Non-Clinical, Quality/Manufacturing, GTS, Pharmacovigilance and Regulatory Compliance. This position will also play a key role in… more
- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... opinion leader interactions related to the disease area(s); partners with Medical Affairs , Commercial and other functions in these activities as required, consistent… more