Executive Director, Regulatory Affairs Liaison Job at Merck, Rahway, NJ

  • Merck
  • Rahway, NJ

Job Description

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

Job Tags

Worldwide

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