Head of CMC Regulatory Affairs – Small Molecules
Gilead Sciences
June 27, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Responsibilities:
- Lead CMC teams/groups to support CMC regulatory affairs goals and contribute to global regulatory initiatives.
- Lead global CMC regulatory strategies, including risk mitigation for right-first-time approvals.
- Develop global CMC regulatory strategies to support lifecycle product/process development while maintaining global licensure and right to operate.
- Execute global CMC regulatory plans; oversee submission/approval process with PDM, Regulatory Affairs, and Clinical Development.
- Lead integration/implementation of CMC Team Leaders and CMC Strategies (Regulatory Scientists).
- Develop regulatory strategies/solutions for complex CMC challenges for Clinical through Growth (newly approved) submissions and commercial registration (including risk mitigation).
- Interpret/implement ICH guidelines to enable an approved/harmonized regulatory control strategy.
- Ensure global regulatory conformance/consistency for assigned products.
- Partner across CMC Regulatory Affairs, PDM, and other groups to promote regulatory innovation and novel approaches.
- Develop relationships with local/global internal and external partners.
- Lead CMC strategies, assess risks, and develop contingency plans for major, complex applications.
- Influence in a highly matrixed organization; drive continuous improvement/talent development in Small Molecules.
Qualifications:
- Scientific degree; 16+ years directly relevant experience (small molecule development, global CMC regulatory affairs/technical), or 14+ years with MA/MS, PhD, PharmD, or MD.
- Track record leading CMC regulatory initiatives/innovative strategies and international forums (e.g., ICH, PhRMA, ISPE, IQ).
- Experience leading NDA/BLA submissions/approvals and global Health Authority interactions.
- Sound judgment; leadership of complex groups; strong strategic acumen, collaboration, and communication.
Benefits (as stated): Salary range $302,005.00–$390,830.00; may include annual bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday.
- Lead CMC teams/groups to support CMC regulatory affairs goals and contribute to global regulatory initiatives.
- Lead global CMC regulatory strategies, including risk mitigation for right-first-time approvals.
- Develop global CMC regulatory strategies to support lifecycle product/process development while maintaining global licensure and right to operate.
- Execute global CMC regulatory plans; oversee submission/approval process with PDM, Regulatory Affairs, and Clinical Development.
- Lead integration/implementation of CMC Team Leaders and CMC Strategies (Regulatory Scientists).
- Develop regulatory strategies/solutions for complex CMC challenges for Clinical through Growth (newly approved) submissions and commercial registration (including risk mitigation).
- Interpret/implement ICH guidelines to enable an approved/harmonized regulatory control strategy.
- Ensure global regulatory conformance/consistency for assigned products.
- Partner across CMC Regulatory Affairs, PDM, and other groups to promote regulatory innovation and novel approaches.
- Develop relationships with local/global internal and external partners.
- Lead CMC strategies, assess risks, and develop contingency plans for major, complex applications.
- Influence in a highly matrixed organization; drive continuous improvement/talent development in Small Molecules.
Qualifications:
- Scientific degree; 16+ years directly relevant experience (small molecule development, global CMC regulatory affairs/technical), or 14+ years with MA/MS, PhD, PharmD, or MD.
- Track record leading CMC regulatory initiatives/innovative strategies and international forums (e.g., ICH, PhRMA, ISPE, IQ).
- Experience leading NDA/BLA submissions/approvals and global Health Authority interactions.
- Sound judgment; leadership of complex groups; strong strategic acumen, collaboration, and communication.
Benefits (as stated): Salary range $302,005.00–$390,830.00; may include annual bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instructions:
- Apply via the Internal Career Opportunities portal in Workday.