Executive Director, Regulatory Affairs
Merck
June 26, 2026
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Primary Responsibilities:
- Lead Regulatory CMC team for antibody-drug conjugates (ADCs) in late-stage development and life cycle management.
- Own global CMC regulatory strategy, global registration, and post-approval strategy.
- Lead regulatory CMC deliverables for clinical studies through initial market applications and post-approval to ensure global commercial supply.
- Ensure quality of CMC submissions and interactions with Health Authorities; review major documents and responses.
- Communicate CMC regulatory strategy, risk, and plan across GRACS CMC, R&D, Manufacturing, and Global Human Health.
- Drive cross-functional partnerships; negotiate/influence internally and with regulatory agencies.
- Represent GRACS CMC in executive meetings/leadership forums.
- Monitor regulatory environment; perform and approve risk assessments and mitigation.
- Direct resourcing and prioritization; develop innovative solutions.
- Manage, coach, and develop CMC staff.
Education:
- BS in Biology, Chemistry, Pharmacy, Engineering, or related field; PhD preferred.
Required Experience/Skills:
- 15+ years pharma industry CMC technical experience.
- 10+ years Regulatory CMC, leading global programs (pre-approval/post-marketing); ADC experience preferred.
- 7+ years people management/leadership (larger groups strongly preferred).
- Demonstrated CMC regulatory/dossier leadership; experience with change management; recruiting/training; matrix effectiveness; 10% travel.
Required/Relevant Skills:
- ADC, biopharmaceuticals/biopharmaceutics, eCTD, regulatory submissions/reporting/risk, regulatory CMC/compliance audits, project management, mentoring/people leadership, confidentiality.
Benefits:
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement/401(k), paid holidays/vacation, and sick/compassionate days.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Lead Regulatory CMC team for antibody-drug conjugates (ADCs) in late-stage development and life cycle management.
- Own global CMC regulatory strategy, global registration, and post-approval strategy.
- Lead regulatory CMC deliverables for clinical studies through initial market applications and post-approval to ensure global commercial supply.
- Ensure quality of CMC submissions and interactions with Health Authorities; review major documents and responses.
- Communicate CMC regulatory strategy, risk, and plan across GRACS CMC, R&D, Manufacturing, and Global Human Health.
- Drive cross-functional partnerships; negotiate/influence internally and with regulatory agencies.
- Represent GRACS CMC in executive meetings/leadership forums.
- Monitor regulatory environment; perform and approve risk assessments and mitigation.
- Direct resourcing and prioritization; develop innovative solutions.
- Manage, coach, and develop CMC staff.
Education:
- BS in Biology, Chemistry, Pharmacy, Engineering, or related field; PhD preferred.
Required Experience/Skills:
- 15+ years pharma industry CMC technical experience.
- 10+ years Regulatory CMC, leading global programs (pre-approval/post-marketing); ADC experience preferred.
- 7+ years people management/leadership (larger groups strongly preferred).
- Demonstrated CMC regulatory/dossier leadership; experience with change management; recruiting/training; matrix effectiveness; 10% travel.
Required/Relevant Skills:
- ADC, biopharmaceuticals/biopharmaceutics, eCTD, regulatory submissions/reporting/risk, regulatory CMC/compliance audits, project management, mentoring/people leadership, confidentiality.
Benefits:
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement/401(k), paid holidays/vacation, and sick/compassionate days.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.