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
The role is accountable for defining and executing global regulatory strategy for assigned ophthalmology programs to minimize time to approval

Job Summary

  • The role is accountable for defining and executing global regulatory strategy for assigned ophthalmology programs to minimize time to approval.
  • Candidates must have demonstrated success in securing original NDA/BLA approvals and possess thorough familiarity with worldwide regulatory agencies.
  • The position offers a comprehensive benefits package including medical, dental, vision, retirement benefits, and eligibility for annual bonus and long-term incentives.

Matching Summary

The role is accountable for defining and executing 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
  • Majority in regulatory affairs
  • Secure original NDA/BLA approvals
  • Lead global regulatory strategy
  • Manage Global Regulatory Leads team

Nice-to-have

  • Experience with retinal disease programs
  • Substantial small and large molecule development
  • Prior experience as Global Regulatory Lead
  • Growth mindset and intellectual curiosity
  • Cross-cultural awareness and negotiation skills

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
  • US work authorization required (Visa sponsorship available)

Work Rights

Not specified

Sponsorship: available

Tailored Resume

Cover Letter