Director, Global Regulatory Affairs & Clinical Safety Business Development
Merck
July 02, 2026
Remote friendly (Rahway, NJ)
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 partner deals (e.g., divestitures, mergers/acquisitions, in-licensing, collaborations).
- Provide people management, including oversight of team members and employee development consistent with leadership principles.
- Manage regulatory components of agreements for product acquisitions, collaborations, distribution, comarketing, copromotion, tech transfer, joint ventures, and divestitures.
- Collaborate with Global Regulatory Affairs, Clinical Safety, Corporate Business Development, Clinical Research, Commercial, Manufacturing, and other groups as needed.
- Support development of new Business Development agreements with a regulatory focus for complex deals; update existing agreements as partner relationships evolve.
- Oversee multiple projects with complex integration points and fast-paced timelines; assess issues, gather/process information, develop solutions, and recommend/resolve problems.
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 other 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:
- Apply via https://jobs.merck.com/us/en (application deadline stated on posting).
- 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 partner deals (e.g., divestitures, mergers/acquisitions, in-licensing, collaborations).
- Provide people management, including oversight of team members and employee development consistent with leadership principles.
- Manage regulatory components of agreements for product acquisitions, collaborations, distribution, comarketing, copromotion, tech transfer, joint ventures, and divestitures.
- Collaborate with Global Regulatory Affairs, Clinical Safety, Corporate Business Development, Clinical Research, Commercial, Manufacturing, and other groups as needed.
- Support development of new Business Development agreements with a regulatory focus for complex deals; update existing agreements as partner relationships evolve.
- Oversee multiple projects with complex integration points and fast-paced timelines; assess issues, gather/process information, develop solutions, and recommend/resolve problems.
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 other 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:
- Apply via https://jobs.merck.com/us/en (application deadline stated on posting).