Director, Global Regulatory Affairs & Clinical Safety Business Development
Merck
July 02, 2026
Remote friendly (North Wales, PA)
United States
Medical Affairs
Responsibilities:
- Represent Regulatory Affairs on business development transactions from deal initiation through potential signing.
- Oversee staff managing business development stages: strategy, evaluation, due diligence, contracting, implementation support, and maintenance of regulatory activities for business partner deals.
- Manage regulatory strategy/negotiation/provisions of agreements for product acquisitions, collaborations, distribution, comarketing, copromotion, tech transfer, joint ventures, and divestitures (including divestitures, mergers/acquisitions, in-licensing, collaborations).
- Provide people management, employee development, and management aligned with leadership principles.
- Collaborate with Global Regulatory Affairs and Clinical Safety and with Corporate Business Development, Clinical Research, Commercial, Manufacturing, and other groups as needed.
- Support development of new complex business development agreements with regulatory focus; maintain and update existing agreements as partner relationships evolve.
- Oversee multiple projects with complex integration points and fast-paced timelines; help assess issues, gather/process information, propose solutions, and recommend/resolve.
Education/Qualifications:
- Bachelor’s degree; at least 7 years’ experience in the pharma industry or adjacent field (e.g., Health Authority).
- Advanced degree in Regulatory or another science discipline (preferred).
Required Skills:
- Adaptability, Change Management, Detail-Oriented, Regulatory Affairs Management, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Experience, Regulatory Strategy Development, Regulatory Submissions, Strategic Planning, Strategic Thinking.
Preferred Skills:
- Business Development.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
- Represent Regulatory Affairs on business development transactions from deal initiation through potential signing.
- Oversee staff managing business development stages: strategy, evaluation, due diligence, contracting, implementation support, and maintenance of regulatory activities for business partner deals.
- Manage regulatory strategy/negotiation/provisions of agreements for product acquisitions, collaborations, distribution, comarketing, copromotion, tech transfer, joint ventures, and divestitures (including divestitures, mergers/acquisitions, in-licensing, collaborations).
- Provide people management, employee development, and management aligned with leadership principles.
- Collaborate with Global Regulatory Affairs and Clinical Safety and with Corporate Business Development, Clinical Research, Commercial, Manufacturing, and other groups as needed.
- Support development of new complex business development agreements with regulatory focus; maintain and update existing agreements as partner relationships evolve.
- Oversee multiple projects with complex integration points and fast-paced timelines; help assess issues, gather/process information, propose solutions, and recommend/resolve.
Education/Qualifications:
- Bachelor’s degree; at least 7 years’ experience in the pharma industry or adjacent field (e.g., Health Authority).
- Advanced degree in Regulatory or another science discipline (preferred).
Required Skills:
- Adaptability, Change Management, Detail-Oriented, Regulatory Affairs Management, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Experience, Regulatory Strategy Development, Regulatory Submissions, Strategic Planning, Strategic Thinking.
Preferred Skills:
- Business Development.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).