Head of CMC Regulatory Affairs Small Molecules

Found in: beBee jobs US - 2 weeks ago

Belmont, United States Gilead Sciences, Inc Full time

Head of CMC Regulatory Affairs Small Molecules United States - California - Foster City Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.Head of CMC Regulatory Affairs - Small Molecules KEY RESPONSIBILITIES The Head of CMC Regulatory Affairs - Small Molecules is responsible for Gilead's global portfolio of small molecule products in CMC Regulatory Affairs.In addition, the leader will be recognized as a global thought leader for regulatory science and be accountable for leading the interpretation and implementation of CMC regulatory guidelines, regulations and current environment to assure approvability in high priority regions.The role will report directly to Head of CMC Regulatory Affairs at Gilead.Develop global CMC regulatory strategies to enable life-cycle product/process development strategy while maintaining global licensure and right to operate of Gilead's operations.Lead the execution of these global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead for support with opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.QUALIFICATIONS A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc

  • Head of CMC Regulatory Affairs Small Molecules

    Found in: beBee S US - 1 week ago

    Belmont, United States Gilead Sciences, Inc Full time

    Head of CMC Regulatory Affairs Small Molecules United States - California - Foster City Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.Head of CMC Regulatory Affairs - Small Molecules KEY RESPONSIBILITIES The Head of CMC Regulatory Affairs -...

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