Executive Director, Regulatory Affairs Liaison
Merck
Merck seeks an Executive Director to lead global regulatory strategy for ophthalmology and retinal disease programs in General Medicine. This senior role oversees a team of regulatory leads, manages complex submissions and health authority engagements, and serves as an internal regulatory expert across multiple indications.
Responsibilities
- Develop and implement global regulatory strategy for ophthalmology programs across multiple indications
- Oversee direct reports functioning as global points of accountability for assigned projects and regulatory authority engagement
- Review and approve regulatory deliverables including submissions, communications, protocols, and labeling
- Lead performance management, resource allocation, and staff development for regulatory team members
- Represent company at external regulatory meetings, health authority engagements, and internal governance bodies
Requirements
- B.S./M.S. in biological science with 12+ years drug development experience, majority in regulatory affairs
- M.D./Ph.D. or PharmD. with 9+ years drug development experience and 7+ years in regulatory affairs
- Demonstrated track record securing original NDA/BLA approvals
- Strong scientific knowledge and familiarity with worldwide regulatory agencies
- Leadership experience building and managing high-performing teams
- Outstanding interpersonal, communication, and negotiation skills
- Preferred: ophthalmology and retinal disease regulatory experience
Vacancy posted 5 days ago
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