Executive Director, Regulatory Affairs Liaison

Merck & Co., Inc.

Rahway, NJ, USA
Base: $231,900.00 - $365,000.00; bonus/equity: ann...
Hybrid
12 years drug development experience
Majority in regulatory affairs
Secure original nda/bla approvals
This role is accountable for defining and executing global regulatory strategy specifically for assigned ophthalmology programs to minimize time to approval

Job Summary

  • This role is accountable for defining and executing global regulatory strategy specifically for assigned ophthalmology programs to minimize time to approval.
  • The successful candidate will lead a team of Global Regulatory Leads and serve as an authoritative expert in external engagements with major health authorities.
  • Employees are eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

This role is accountable for defining and executing global regulatory strategy specifically 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
  • Majority in regulatory affairs
  • Secure original NDA/BLA approvals
  • Lead high-performing regulatory teams
  • Global regulatory agency familiarity

Nice-to-have

  • Retinal disease program experience
  • Small and large molecule development
  • Prior Global Regulatory Lead role
  • Cross-cultural awareness skills
  • Strategic negotiation abilities

Key Requirements

  • B.S./M.S. with 12+ years experience
  • M.D./Ph.D./PharmD with 9+ years experience
  • At least 7 years in regulatory affairs
  • Demonstrated success in NDA/BLA approvals
  • Experience building and leading teams

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter