Executive Director, Regulatory Affairs Liaison
Merck
1 month ago
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Position Description
- Executive Director, Regulatory Affairs Liaison (reports to VP, General Medicine). Accountable for defining and executing global regulatory strategy for assigned ophthalmology programs, providing strategic oversight across ophthalmology programs in the General Medicine therapeutic area. Leads and develops a team of Global Regulatory Leads (GRLs), sets standards for regulatory excellence across complex programs, and serves as an authoritative subject matter expert in ophthalmology drug development.
Key Responsibilities
- Oversee development and implementation of global regulatory strategy for ophthalmology and retinal disease programs across multiple indications to minimize time to approval and optimize labeling.
- Oversee direct reports; support them to act as the single global point of accountability for assigned projects, partnering with international regulatory colleagues and engaging global health authorities.
- Oversee strategy, review and approve key regulatory deliverables: submissions, external communications (e.g., press releases), background packages, local registration study protocols, and labeling.
- Lead, manage, and review direct report performance, including regulatory strategy oversight, resource allocation, and staff development.
- Represent the company at external regulatory authority meetings, initiatives, and internal committees as required.
- Provide strategic input into regulatory due diligence for licensing candidate review.
Minimum Education Requirements
- B.S./M.S. in biological science or related discipline with at least 12 years relevant drug development experience (majority in regulatory affairs).
- M.D./Ph.D. or PharmD. with at least 9 years relevant drug development experience (at least 7 years in regulatory).
Required Experience and Skills
- Ability to deliver results independently while aligned with leadership.
- Scientific knowledge, effective communication, and thorough familiarity with worldwide regulatory agencies.
- Demonstrated success securing original NDA/BLA approvals.
- Outstanding interpersonal, communication, and negotiation skills.
- Demonstrated leadership attributes; experience building and leading high-performing teams or projects.
Preferred Experience and Skills
- Regulatory experience in retinal disease and ophthalmology programs.
- People management experience.
- Substantial experience with both small and large molecule development programs.
- Extensive U.S. and international regulatory affairs experience, including prior experience as a Global Regulatory Lead.
Additional Information
- Travel: 10%
- Geographical scope: U.S. and global regulatory responsibility
Application Instructions
- Apply through https://jobs.merck.com/us/en (or via Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Compensation/Benefits
- Salary range: $231,900.00 - $365,000.00
- Eligible for annual bonus and long-term incentive, if applicable.
- Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.
- Executive Director, Regulatory Affairs Liaison (reports to VP, General Medicine). Accountable for defining and executing global regulatory strategy for assigned ophthalmology programs, providing strategic oversight across ophthalmology programs in the General Medicine therapeutic area. Leads and develops a team of Global Regulatory Leads (GRLs), sets standards for regulatory excellence across complex programs, and serves as an authoritative subject matter expert in ophthalmology drug development.
Key Responsibilities
- Oversee development and implementation of global regulatory strategy for ophthalmology and retinal disease programs across multiple indications to minimize time to approval and optimize labeling.
- Oversee direct reports; support them to act as the single global point of accountability for assigned projects, partnering with international regulatory colleagues and engaging global health authorities.
- Oversee strategy, review and approve key regulatory deliverables: submissions, external communications (e.g., press releases), background packages, local registration study protocols, and labeling.
- Lead, manage, and review direct report performance, including regulatory strategy oversight, resource allocation, and staff development.
- Represent the company at external regulatory authority meetings, initiatives, and internal committees as required.
- Provide strategic input into regulatory due diligence for licensing candidate review.
Minimum Education Requirements
- B.S./M.S. in biological science or related discipline with at least 12 years relevant drug development experience (majority in regulatory affairs).
- M.D./Ph.D. or PharmD. with at least 9 years relevant drug development experience (at least 7 years in regulatory).
Required Experience and Skills
- Ability to deliver results independently while aligned with leadership.
- Scientific knowledge, effective communication, and thorough familiarity with worldwide regulatory agencies.
- Demonstrated success securing original NDA/BLA approvals.
- Outstanding interpersonal, communication, and negotiation skills.
- Demonstrated leadership attributes; experience building and leading high-performing teams or projects.
Preferred Experience and Skills
- Regulatory experience in retinal disease and ophthalmology programs.
- People management experience.
- Substantial experience with both small and large molecule development programs.
- Extensive U.S. and international regulatory affairs experience, including prior experience as a Global Regulatory Lead.
Additional Information
- Travel: 10%
- Geographical scope: U.S. and global regulatory responsibility
Application Instructions
- Apply through https://jobs.merck.com/us/en (or via Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Compensation/Benefits
- Salary range: $231,900.00 - $365,000.00
- Eligible for annual bonus and long-term incentive, if applicable.
- Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days.