The Executive Director will define and execute global regulatory strategy for assigned ophthalmology programs to minimize time to approval
Job Summary
The Executive Director will define and execute global regulatory strategy for assigned ophthalmology programs to minimize time to approval.
This senior leader is accountable for overseeing direct reports, setting standards for regulatory excellence, and representing the company at external health authority meetings.
Candidates must have a demonstrated ability to deliver results independently while aligning with leadership and securing original NDA/BLA approvals.
Matching Summary
The Executive Director will define and execute global regulatory strategy for assigned ophthalmology programs to minimize time to approval.
Salary
Base: $231,900.00 - $365,000.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation
Skills & Requirements
Must-have
12 years drug development experience
Majority in regulatory affairs
Secure original NDA/BLA approvals
Lead global regulatory teams
Ophthalmology and retinal disease expertise
Nice-to-have
Experience with small and large molecules
Prior Global Regulatory Lead role
Strong negotiation and communication skills
Cross-cultural awareness
Strategic input into due diligence
Key Requirements
B.S./M.S. with 12+ years experience or M.D./Ph.D./PharmD with 9+ years
At least 7 years in regulatory affairs (for advanced degrees)
Substantial experience in U.S. and international regulatory affairs