Direct experience with regional chemistry reviewers
Biologics portfolio regulatory strategy
This role is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio to ensure global approvals
Job Summary
This role is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio to ensure global approvals.
The position requires leading risk assessments on major global CMC regulatory issues and maintaining a proactive awareness of registration requirements.
Gilead offers a competitive salary range, discretionary bonuses, stock-based incentives, and comprehensive benefits including medical, dental, and vision insurance.
Matching Summary
This role is responsible for defining regulatory strategy for one or more molecules in the Biologics portfolio to ensure global approvals.
Salary
Base: $182,070.00 - $235,620.00; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives eligible; Benefits: Medical, dental, vision, life insurance, and paid time off
Skills & Requirements
Must-have
10+ years Regulatory Affairs experience
Direct experience with regional chemistry reviewers
Biologics portfolio regulatory strategy
ICH format and content requirements knowledge
Global CMC submission management
Nice-to-have
Previous management experience
Regulatory Affairs Certification
Advanced degrees including PhD or MS
Strong verbal and written communication skills
Experience in industry trade groups
Key Requirements
10+ years of experience in Regulatory Affairs
Direct experience working with regional chemistry reviewers