Executive Director, Regulatory Affairs Liaison
Merck
June 24, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
Position Description
The Executive Director, Regulatory Affairs Liaison reports to the VP, General Medicine, and is accountable for defining and executing global regulatory strategy for assigned ophthalmology programs. Provides strategic oversight across ophthalmology programs in General Medicine, aligns regulatory objectives with development, evidence-generation, and commercialization priorities, leads/develops Global Regulatory Leads (GRLs), and serves as an ophthalmology drug-development subject matter expert.
Key Responsibilities
- Oversee global regulatory strategy for ophthalmology/retinal disease programs for multiple indications to minimize time to approval and optimize labeling.
- Provide oversight to direct reports as single global point of accountability; partner with international regulatory colleagues and engage global health authorities.
- Oversee/review/approve key regulatory deliverables (submissions, external communications, background packages, local registration study protocols, labeling).
- Lead/manage/review direct report performance, including resource allocation and staff development.
- Represent the company in external regulatory initiatives/meetings and internal committees.
- Provide strategic input into regulatory due diligence for licensing candidate review.
Minimum Education Requirements
- B.S./M.S. in biological science or related discipline + 12+ years relevant drug development (majority in regulatory), or
- M.D./Ph.D./PharmD + 9+ years relevant drug development (at least 7 years in regulatory).
Required Experience and Skills
- Ability to deliver results independently while aligned with leadership.
- Scientific knowledge, effective communication, worldwide regulatory agency familiarity.
- Success securing original NDA/BLA approvals.
- Interpersonal, communication, negotiation skills.
- Leadership; experience building/leading high-performing teams/projects.
Preferred Experience and Skills
- Retinal disease/ophthalmology regulatory experience; people management.
- Experience with small and large molecule programs.
- U.S. and international regulatory affairs experience; prior Global Regulatory Lead experience.
Additional Information
- Travel: 10%; Geographical scope: U.S. and global regulatory responsibility.
Benefits (as stated)
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application Instructions
Apply via https://jobs.merck.com/us/en (current employees: Workday Jobs Hub).
The Executive Director, Regulatory Affairs Liaison reports to the VP, General Medicine, and is accountable for defining and executing global regulatory strategy for assigned ophthalmology programs. Provides strategic oversight across ophthalmology programs in General Medicine, aligns regulatory objectives with development, evidence-generation, and commercialization priorities, leads/develops Global Regulatory Leads (GRLs), and serves as an ophthalmology drug-development subject matter expert.
Key Responsibilities
- Oversee global regulatory strategy for ophthalmology/retinal disease programs for multiple indications to minimize time to approval and optimize labeling.
- Provide oversight to direct reports as single global point of accountability; partner with international regulatory colleagues and engage global health authorities.
- Oversee/review/approve key regulatory deliverables (submissions, external communications, background packages, local registration study protocols, labeling).
- Lead/manage/review direct report performance, including resource allocation and staff development.
- Represent the company in external regulatory initiatives/meetings and internal committees.
- Provide strategic input into regulatory due diligence for licensing candidate review.
Minimum Education Requirements
- B.S./M.S. in biological science or related discipline + 12+ years relevant drug development (majority in regulatory), or
- M.D./Ph.D./PharmD + 9+ years relevant drug development (at least 7 years in regulatory).
Required Experience and Skills
- Ability to deliver results independently while aligned with leadership.
- Scientific knowledge, effective communication, worldwide regulatory agency familiarity.
- Success securing original NDA/BLA approvals.
- Interpersonal, communication, negotiation skills.
- Leadership; experience building/leading high-performing teams/projects.
Preferred Experience and Skills
- Retinal disease/ophthalmology regulatory experience; people management.
- Experience with small and large molecule programs.
- U.S. and international regulatory affairs experience; prior Global Regulatory Lead experience.
Additional Information
- Travel: 10%; Geographical scope: U.S. and global regulatory responsibility.
Benefits (as stated)
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application Instructions
Apply via https://jobs.merck.com/us/en (current employees: Workday Jobs Hub).