Gilead Sciences is seeking a Head of CMC Regulatory Affairs for Small Molecules, responsible for leading regulatory strategies and teams to ensure successful product submissions and compliance globally. The ideal candidate should have extensive experience in CMC regulatory affairs, particularly in small molecule development, and demonstrate strong leadership and strategic skills
Job Summary
The role involves leading CMC teams to support global regulatory goals and ensuring right-first-time approvals for product submissions.
Candidates must demonstrate expertise in interpreting ICH guidelines to maintain global licensure and operational compliance for small molecule products.
Gilead offers a competitive salary range of $302,005.00 to $390,830.00 along with discretionary bonuses, stock incentives, and comprehensive benefits.
Matching Summary
Match Score: 85
Gilead Sciences is seeking a Head of CMC Regulatory Affairs for Small Molecules, responsible for leading regulatory strategies and teams to ensure successful product submissions and compliance globally. The ideal candidate should have extensive experience in CMC regulatory affairs, particularly in small molecule development, and demonstrate strong leadership and strategic skills.
Salary
Base: $302,005.00 - $390,830.00; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Medical, dental, vision, life insurance, and paid time off
Skills & Requirements
Must-have
Small molecule development experience
Global CMC regulatory strategy leadership
NDA/BLA submission and approval management
ICH guideline interpretation and implementation
Risk mitigation for complex applications
Matrix organization influence without authority
Nice-to-have
Experience in international regulatory forums
Promoting novel regulatory approaches
Driving cultural evolution and talent development
Collaborative relationship building skills
Key Requirements
16 years experience with BA/BS or 14 years with advanced degree
Scientific degree in small molecule development
Track record of leading NDA/BLA submissions
Demonstrated organizational leadership at enterprise level