Executive Director, Regulatory Affairs

Role: 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 regulatory CMC submissions supporting clinical studies, initial market applications, and post-approval for global commercial supply.
- Ensure quality of CMC submissions and interactions with Health Authorities; provide critical review of major documents and responses to authority questions.
- Communicate CMC strategy, risk, mitigation, and plans cross-functionally (GRACS, R&D, Manufacturing, GHH) and to executive leadership.
- Build cross-functional partnerships; negotiate and influence internally and with regulatory agencies.
- Represent GRACS CMC at executive forums; monitor regulatory changes with strategic impact.
- Conduct risk assessments; approve risk/mitigation for key decisions.
- Plan and resource regulatory CMC execution; prioritize work with R&D, Manufacturing, and GHH.
- Manage, coach, and develop CMC staff; identify talent and broaden regulatory CMC capabilities.

Education:
- BS in Biology, Chemistry, Pharmacy, Engineering, or related field.
- Advanced degree (PhD preferred) in Biologics/Pharmaceutical Sciences/Engineering or related.

Required Experience/Skills:
- 15+ years pharma industry with CMC technical experience.
- 10+ years Regulatory CMC leading global programs (pre-approval/post-marketing); ADC experience preferred.
- 7+ years people management/leadership.
- Leadership in CMC regulatory strategy and dossier management; change/process improvement experience.
- Flexibility in matrix environments; 10% travel.

Required/Application:
- Apply via https://jobs.merck.com/us/en (deadline listed on posting).