Executive Director, Regulatory Affairs Liaison
Merck
1 month ago
Remote friendly (Boston, MA)
United States
Corporate Functions
Key Responsibilities
- Oversee development and implementation of global regulatory strategy for ophthalmology/retinal disease programs across 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 with international regulatory colleagues and global health authorities.
- Oversee strategy, review, and approve key regulatory deliverables (submissions, external communications, background packages, local registration study protocols, labeling).
- Lead, manage, and review direct reports’ performance, including regulatory strategy oversight, resource allocation, and staff development.
- Represent the company at external regulatory initiatives/authority 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; minimum 12 years relevant drug development experience (majority in regulatory).
- M.D./Ph.D. or PharmD.; minimum 9 years relevant drug development experience (at least 7 years in regulatory).
Required Experience & Skills
- Independently delivers results aligned with leadership.
- Scientific knowledge, effective communication, and thorough familiarity with worldwide regulatory agencies.
- Success securing original NDA/BLA approvals.
- Interpersonal, communication, and negotiation skills; leadership experience building high-performing teams/projects.
Preferred Experience & Skills
- Retinal disease and ophthalmology regulatory experience; people management experience.
- Experience with small and large molecule development programs.
- U.S. and international regulatory affairs experience; prior Global Regulatory Lead experience.
Benefits (as stated)
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application Instructions
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Deadline is stated on the posting. Requisition ID: R391555.
- Oversee development and implementation of global regulatory strategy for ophthalmology/retinal disease programs across 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 with international regulatory colleagues and global health authorities.
- Oversee strategy, review, and approve key regulatory deliverables (submissions, external communications, background packages, local registration study protocols, labeling).
- Lead, manage, and review direct reports’ performance, including regulatory strategy oversight, resource allocation, and staff development.
- Represent the company at external regulatory initiatives/authority 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; minimum 12 years relevant drug development experience (majority in regulatory).
- M.D./Ph.D. or PharmD.; minimum 9 years relevant drug development experience (at least 7 years in regulatory).
Required Experience & Skills
- Independently delivers results aligned with leadership.
- Scientific knowledge, effective communication, and thorough familiarity with worldwide regulatory agencies.
- Success securing original NDA/BLA approvals.
- Interpersonal, communication, and negotiation skills; leadership experience building high-performing teams/projects.
Preferred Experience & Skills
- Retinal disease and ophthalmology regulatory experience; people management experience.
- Experience with small and large molecule development programs.
- U.S. and international regulatory affairs experience; prior Global Regulatory Lead experience.
Benefits (as stated)
- Annual bonus and long-term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application Instructions
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Deadline is stated on the posting. Requisition ID: R391555.