Executive Director, Regulatory Affairs Liaison

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