Head of CMC Regulatory Affairs - Small Molecules
$302.01k - $390.83kGilead
Gilead seeks a Head of CMC Regulatory Affairs for small molecules to lead global chemistry, manufacturing, and controls strategies across the product portfolio. The role involves overseeing CMC regulatory submissions, developing risk mitigation strategies for approvals, and ensuring lifecycle compliance across clinical and commercial products. The successful candidate will direct cross-functional teams, apply ICH guidelines expertise, and drive regulatory innovation within a matrixed organization.
Responsibilities
- Lead CMC teams to support product and portfolio regulatory affairs goals and global initiatives
- Develop and execute global CMC regulatory strategies for right first-time approvals across submissions
- Oversee CMC regulatory plans from clinical through commercialization, managing submissions and approvals
- Ensure regulatory conformance and consistency for assigned products globally
- Partner across functional groups to advance regulatory innovation and resolve complex CMC challenges
Requirements
- Bachelor's degree in science with 16+ years small molecule CMC regulatory experience, or Master's/PhD with 14+ years
- Proven leadership of CMC regulatory affairs initiatives and innovative regulatory strategies
- Experience leading NDA/BLA submissions and approvals with global health authority interactions
- Demonstrated organizational leadership at functional and enterprise levels
- Strategic acumen, collaboration, and communication skills
- Track record in international regulatory or industry forums on policy matters
Compensation: $302,005.00 - $390,830.00 base, plus discretionary annual bonus and stock-based long-term incentives
Vacancy posted a month ago
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