Executive Director, Regulatory Affairs
Merck
2 months ago
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Primary Responsibilities:
- Lead the Regulatory CMC team for antibody-drug conjugates (ADCs) in late-stage development and life cycle management.
- Own global CMC regulatory strategy; lead global registration and post-approval strategy for new products.
- Lead CMC deliverables including submissions supporting clinical studies, market applications, and post-approval to ensure global commercial supply.
- Ensure quality of CMC submissions, correspondence, and interactions with Health Authorities; review major documents and responses to Health Authority questions.
- Communicate CMC regulatory strategy, risk, mitigation, and overall plan across GRACS, R&D, Manufacturing, GHH, product development, and executive management.
- Build cross-functional partnerships; negotiate/influence internally and with regulatory agencies.
- Monitor regulatory environment changes; perform risk assessments and approve risk/mitigation for strategic CMC decisions.
- Develop resource plans and allocate resources to meet team CMC deliverables; prioritize work with R&D, Manufacturing, and GHH.
- Manage, coach, and develop CMC staff (performance management, talent identification, and retention).
Education:
- Minimum B.S. in Biology, Chemistry, Pharmacy, Engineering, or related field; PhD preferred.
Required Experience and Skills:
- 15+ years pharmaceutical industry experience with CMC technical functions.
- 10+ years Regulatory CMC leadership (pre-approval or post-marketing); ADC experience highly preferred.
- 7+ years people management/leadership (larger groups strongly preferred).
- Demonstrated ability to influence across divisions and proactively minimize regulatory risk.
- Recognized CMC regulatory strategy and dossier management leader; experience presenting at industry/agency meetings.
- Experience driving organizational/process change and continuous improvement.
- Ability to recruit/train/develop staff; matrix environment flexibility.
- Travel: 10%.
Required/Technical Skills:
- Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, eCTD, Regulatory CMC, Regulatory Submissions, Regulatory Risk, Regulatory Reporting, Project Management, Regulatory Compliance Audits, risk analysis.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline stated on posting.
- Lead the Regulatory CMC team for antibody-drug conjugates (ADCs) in late-stage development and life cycle management.
- Own global CMC regulatory strategy; lead global registration and post-approval strategy for new products.
- Lead CMC deliverables including submissions supporting clinical studies, market applications, and post-approval to ensure global commercial supply.
- Ensure quality of CMC submissions, correspondence, and interactions with Health Authorities; review major documents and responses to Health Authority questions.
- Communicate CMC regulatory strategy, risk, mitigation, and overall plan across GRACS, R&D, Manufacturing, GHH, product development, and executive management.
- Build cross-functional partnerships; negotiate/influence internally and with regulatory agencies.
- Monitor regulatory environment changes; perform risk assessments and approve risk/mitigation for strategic CMC decisions.
- Develop resource plans and allocate resources to meet team CMC deliverables; prioritize work with R&D, Manufacturing, and GHH.
- Manage, coach, and develop CMC staff (performance management, talent identification, and retention).
Education:
- Minimum B.S. in Biology, Chemistry, Pharmacy, Engineering, or related field; PhD preferred.
Required Experience and Skills:
- 15+ years pharmaceutical industry experience with CMC technical functions.
- 10+ years Regulatory CMC leadership (pre-approval or post-marketing); ADC experience highly preferred.
- 7+ years people management/leadership (larger groups strongly preferred).
- Demonstrated ability to influence across divisions and proactively minimize regulatory risk.
- Recognized CMC regulatory strategy and dossier management leader; experience presenting at industry/agency meetings.
- Experience driving organizational/process change and continuous improvement.
- Ability to recruit/train/develop staff; matrix environment flexibility.
- Travel: 10%.
Required/Technical Skills:
- Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, eCTD, Regulatory CMC, Regulatory Submissions, Regulatory Risk, Regulatory Reporting, Project Management, Regulatory Compliance Audits, risk analysis.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline stated on posting.