Head of CMC Regulatory Affairs - Small Molecules

1w1 week ago

Gilead Sciences

Foster City, US · Full-time · $302,005 – $390,830

About this role

At Gilead, we’re creating a healthier world by tackling diseases such as HIV, viral hepatitis, COVID-19 and cancer. We develop therapies that improve lives and ensure global access. This role leads CMC teams to support product and portfolio regulatory affairs goals.

Lead global CMC regulatory strategies with risk mitigation for right first-time approvals. Develop strategies enabling life-cycle product development while maintaining global licensure. Oversee submission and approval processes in partnership with PDM, Regulatory Affairs, and Clinical Development.

Partner across CMC Regulatory Affairs, PDM, and other functions to promote regulatory innovation and novel approaches. Build collaborative relationships with local and global internal and external partners. Exercise expertise in ICH guidelines for harmonized regulatory control strategies.

Drive continuous improvement and cultural evolution in the Small Molecules organization. Model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities. Develop talent at all levels and influence without positional authority in a matrixed organization.

Requirements

Scientific degree with 16 years relevant experience in small molecule development, global CMC regulatory affairs, and CMC technical areas (BA/BS)
Or 14 years experience with MA/MS, PhD, PharmD, or MD in same areas
Success in influencing without positional authority in highly matrixed organization
Expertise in global CMC regulatory strategies and risk mitigation
Experience leading major complex regulatory applications
Demonstrated leadership in interpreting ICH guidelines
Ability to partner across functions for regulatory innovation

Responsibilities

Lead CMC teams/groups to support CMC product and portfolio regulatory affairs goals
Lead global CMC regulatory strategies, including risk mitigation strategies for right first-time approvals
Develop global CMC regulatory strategies to enable life-cycle product/process development
Lead execution of global CMC regulatory plans, overseeing submissions and approvals
Lead integration and implementation of CMC Team Leaders and CMC Strategies
Develop regulatory strategies for complex CMC challenges from clinical through commercial
Exercise expertise in interpretation and implementation of ICH guidelines
Ensure regulatory conformance and consistency for assigned products globally