Executive Director, Regulatory Affairs Liaison

Merck & Co., Inc.

Base: $231,900.00 - $365,000.00; bonus/equity: ann...
Hybrid
12 years drug development experience
Regulatory affairs expertise in ophthalmology
Nda/bla approval delivery record
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 serving as an authoritative expert in ophthalmology drug development.
  • The successful candidate will be eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k) retirement plans.

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: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 12 years drug development experience
  • Regulatory affairs expertise in ophthalmology
  • NDA/BLA approval delivery record
  • Global health authority engagement
  • Team leadership of Global Regulatory Leads

Nice-to-have

  • Experience with small and large molecule development
  • Prior Global Regulatory Lead role
  • Retinal disease program background
  • Cross-cultural awareness and negotiation skills
  • Strategic input into licensing due diligence

Key Requirements

  • B.S./M.S. with 12+ years experience or M.D./Ph.D./PharmD with 9+ years
  • Minimum 7 years in regulatory affairs for advanced degrees
  • Demonstrated success securing original NDA/BLA approvals
  • Extensive U.S. and international regulatory affairs experience

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter