Executive Director, Regulatory Affairs Liaison
Merck
June 24, 2026
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Position Description
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 the General Medicine Therapeutic Area, ensuring regulatory objectives align with development, evidence-generation, and commercialization priorities. Leads and develops a team of Global Regulatory Leads (GRLs), sets standards for regulatory excellence across multiple complex programs, and serves as an authoritative regulatory expert in ophthalmology drug development.
Key Responsibilities
- Oversee development and implementation of global regulatory strategy for ophthalmology and retinal disease programs for multiple indications to minimize time to approval and optimize labeling.
- Provide oversight for direct reports; act as single global point of accountability for assigned projects; partner with international regulatory colleagues and engage global health authorities.
- Oversee strategy, review, and approve key regulatory deliverables (submissions, external communications such as press releases, background packages, local registration study protocols, and labeling) for accuracy and consistency.
- Lead, manage, and review direct report performance, including regulatory strategy oversight, resource allocation, and staff development.
- Represent the company at external initiatives, regulatory authority meetings, and internal committees as required.
- Provide strategic input into regulatory due diligence for licensing candidate review.
Minimum Education
- B.S./M.S. in biological science or related discipline; minimum 12 years relevant drug development experience, majority in regulatory affairs.
- M.D./Ph.D. or PharmD.; minimum 9 years relevant drug development experience, with at least 7 years in regulatory.
Required Experience and Skills
- Deliver results independently while aligned with leadership.
- Scientific knowledge, effective communication, and familiarity with worldwide regulatory agencies.
- Success securing original NDA/BLA approvals.
- Interpersonal, communication, and negotiation skills.
- Leadership experience building and leading high-performing teams/projects.
Preferred Experience and Skills
- Regulatory experience in retinal disease and ophthalmology programs.
- People management experience.
- Substantial small and large molecule development experience.
- Extensive U.S. and international regulatory affairs experience, including prior Global Regulatory Lead experience.
Additional Information
- Travel: 10%. Scope: U.S. and global regulatory responsibility.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply no later than 11:59:59PM the day before the posting end date (06/26/2026). Requisition ID: R391555.
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 the General Medicine Therapeutic Area, ensuring regulatory objectives align with development, evidence-generation, and commercialization priorities. Leads and develops a team of Global Regulatory Leads (GRLs), sets standards for regulatory excellence across multiple complex programs, and serves as an authoritative regulatory expert in ophthalmology drug development.
Key Responsibilities
- Oversee development and implementation of global regulatory strategy for ophthalmology and retinal disease programs for multiple indications to minimize time to approval and optimize labeling.
- Provide oversight for direct reports; act as single global point of accountability for assigned projects; partner with international regulatory colleagues and engage global health authorities.
- Oversee strategy, review, and approve key regulatory deliverables (submissions, external communications such as press releases, background packages, local registration study protocols, and labeling) for accuracy and consistency.
- Lead, manage, and review direct report performance, including regulatory strategy oversight, resource allocation, and staff development.
- Represent the company at external initiatives, regulatory authority meetings, and internal committees as required.
- Provide strategic input into regulatory due diligence for licensing candidate review.
Minimum Education
- B.S./M.S. in biological science or related discipline; minimum 12 years relevant drug development experience, majority in regulatory affairs.
- M.D./Ph.D. or PharmD.; minimum 9 years relevant drug development experience, with at least 7 years in regulatory.
Required Experience and Skills
- Deliver results independently while aligned with leadership.
- Scientific knowledge, effective communication, and familiarity with worldwide regulatory agencies.
- Success securing original NDA/BLA approvals.
- Interpersonal, communication, and negotiation skills.
- Leadership experience building and leading high-performing teams/projects.
Preferred Experience and Skills
- Regulatory experience in retinal disease and ophthalmology programs.
- People management experience.
- Substantial small and large molecule development experience.
- Extensive U.S. and international regulatory affairs experience, including prior Global Regulatory Lead experience.
Additional Information
- Travel: 10%. Scope: U.S. and global regulatory responsibility.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply no later than 11:59:59PM the day before the posting end date (06/26/2026). Requisition ID: R391555.