Executive Director, Regulatory Affairs
Merck
June 26, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
Executive Director, Chemistry, Manufacturing, Control for Biologics (Biologics-CMC)
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 for new products.
- Lead CMC regulatory deliverables from clinical-study submissions through initial market applications and post-approval to support global commercial supply.
- Ensure quality of CMC submissions/correspondence and manage interactions with Health Authorities; provide critical review and responses to questions.
- Communicate CMC regulatory strategy, risks, mitigations, and plans across GRACS CMC, R&D, Manufacturing, GHH, and executives; build cross-functional partnerships.
- Monitor regulatory environment changes; perform and approve risk assessments and mitigation for strategic decisions.
- Develop plans, resource needs, and allocation; prioritize work with R&D/Manufacturing/GHH.
- Manage, coach, and develop CMC staff.
Education
- BS in Biology, Chemistry, Pharmacy, Engineering, or relevant field; PhD preferred in biologics/pharmaceutical sciences/engineering.
Required Experience/Skills
- 15+ years in Pharma with CMC technical functions; 10+ years in Regulatory CMC (global pre/post-approval); direct ADC experience preferred.
- 7+ years people management/leadership.
- Broad expertise in CMC regulatory strategy and dossier management; change/process improvement experience.
- Ability to lead in matrix environments; 10% travel.
Skills (Required)
- Regulatory CMC, regulatory submissions (eCTD), regulatory risk/compliance, regulatory development/monitoring/reporting, project management, mentoring/people leadership.
Benefits (if applicable)
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application Instructions
- Apply at https://jobs.merck.com/us/en (deadline listed on the posting).
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 for new products.
- Lead CMC regulatory deliverables from clinical-study submissions through initial market applications and post-approval to support global commercial supply.
- Ensure quality of CMC submissions/correspondence and manage interactions with Health Authorities; provide critical review and responses to questions.
- Communicate CMC regulatory strategy, risks, mitigations, and plans across GRACS CMC, R&D, Manufacturing, GHH, and executives; build cross-functional partnerships.
- Monitor regulatory environment changes; perform and approve risk assessments and mitigation for strategic decisions.
- Develop plans, resource needs, and allocation; prioritize work with R&D/Manufacturing/GHH.
- Manage, coach, and develop CMC staff.
Education
- BS in Biology, Chemistry, Pharmacy, Engineering, or relevant field; PhD preferred in biologics/pharmaceutical sciences/engineering.
Required Experience/Skills
- 15+ years in Pharma with CMC technical functions; 10+ years in Regulatory CMC (global pre/post-approval); direct ADC experience preferred.
- 7+ years people management/leadership.
- Broad expertise in CMC regulatory strategy and dossier management; change/process improvement experience.
- Ability to lead in matrix environments; 10% travel.
Skills (Required)
- Regulatory CMC, regulatory submissions (eCTD), regulatory risk/compliance, regulatory development/monitoring/reporting, project management, mentoring/people leadership.
Benefits (if applicable)
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application Instructions
- Apply at https://jobs.merck.com/us/en (deadline listed on the posting).