Executive Director, Regulatory Affairs

Merck & Co., Inc.

Base: $255,800.00 - $402,700.00; bonus/equity: ann...
Hybrid (3 days onsite, 1 day remote)
15 years pharmaceutical industry experience
10 years regulatory cmc leadership
7 years people management experience
The Executive Director, Regulatory Affairs position at Merck & Co., Inc. is a leadership role focused on overseeing the Chemistry, Manufacturing, and Control (CMC) strategy for biologics, specifically antibody-drug conjugates (ADCs). The ideal candidate will have extensive experience in regulatory CMC functions, team leadership, and a strong understanding of global regulatory processes

Job Summary

  • The Executive Director leads the Regulatory CMC team responsible for antibody-drug conjugates in late-stage development and life cycle management.
  • This role ensures rigorous global CMC regulatory strategy and delivery of high-quality submissions for new modality biologics products.
  • The successful candidate will manage a team of professionals, drive cross-functional alignment across R&D and Manufacturing, and ensure compliance with Health Authorities.

Matching Summary

Match Score: 85

The Executive Director, Regulatory Affairs position at Merck & Co., Inc. is a leadership role focused on overseeing the Chemistry, Manufacturing, and Control (CMC) strategy for biologics, specifically antibody-drug conjugates (ADCs). The ideal candidate will have extensive experience in regulatory CMC functions, team leadership, and a strong understanding of global regulatory processes.

Salary

Base: $255,800.00 - $402,700.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays

Skills & Requirements

Must-have

  • 15 years pharmaceutical industry experience
  • 10 years Regulatory CMC leadership
  • 7 years people management experience
  • Antibody-Drug Conjugates (ADC) expertise
  • Global regulatory strategy execution

Nice-to-have

  • Advanced degree in Pharmaceutical Sciences
  • Experience with late-stage biologics
  • Cross-functional partnership skills
  • Risk assessment capabilities
  • Influencing executive stakeholders

Key Requirements

  • Minimum B.S. degree required; PhD preferred
  • 15+ years in Pharmaceutical Industry
  • 10+ years in Regulatory CMC
  • 7+ years People Management experience
  • Direct ADC experience highly preferred

Work Rights

Not specified

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