Executive Director, Regulatory Affairs Liaison
Merck
1 month ago
Remote friendly (North Wales, PA)
United States
Corporate Functions
Executive Director, Regulatory Affairs Liaison (Global Regulatory Strategy)
Key Responsibilities:
- Oversee development and implementation of global regulatory strategy for ophthalmology/retinal disease programs for multiple indications to minimize time to approval and optimize labeling.
- Provide oversight to direct reports; serve as single global point of accountability for assigned projects; partner with international regulatory colleagues and engage global health authorities.
- Oversee strategy, review and approval of key regulatory deliverables: submissions, external communications, background packages, local registration study protocols, and labeling.
- Lead, manage, and review direct report performance, including regulatory strategy, resource allocation, and staff development.
- Represent the company at external initiatives, regulatory authority meetings, and internal committees.
- Provide strategic input into regulatory due diligence for licensing candidate review.
Minimum Education:
- B.S./M.S. (biological science or related); 12+ years relevant drug development experience (majority in regulatory).
- OR M.D./Ph.D./PharmD; 9+ years relevant drug development experience (at least 7 years in regulatory).
Required Skills/Experience:
- Independent delivery aligned with leadership; scientific knowledge; effective communication; worldwide regulatory agency familiarity.
- Success securing original NDA/BLA approvals.
- Strong interpersonal/negotiation skills; leadership experience building high-performing teams.
Preferred:
- Retinal disease/ophthalmology regulatory experience; people management.
- Experience across small/large molecule programs.
- Extensive U.S./international regulatory experience; prior Global Regulatory Lead experience.
Additional:
- Travel: 10%; Geographical scope: U.S. and global regulatory responsibility.
- Benefits: medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days; annual bonus and long-term incentive (if applicable).
Apply: https://jobs.merck.com/us/en (or Workday Jobs Hub). Requisition ID: R391555.
Key Responsibilities:
- Oversee development and implementation of global regulatory strategy for ophthalmology/retinal disease programs for multiple indications to minimize time to approval and optimize labeling.
- Provide oversight to direct reports; serve as single global point of accountability for assigned projects; partner with international regulatory colleagues and engage global health authorities.
- Oversee strategy, review and approval of key regulatory deliverables: submissions, external communications, background packages, local registration study protocols, and labeling.
- Lead, manage, and review direct report performance, including regulatory strategy, resource allocation, and staff development.
- Represent the company at external initiatives, regulatory authority meetings, and internal committees.
- Provide strategic input into regulatory due diligence for licensing candidate review.
Minimum Education:
- B.S./M.S. (biological science or related); 12+ years relevant drug development experience (majority in regulatory).
- OR M.D./Ph.D./PharmD; 9+ years relevant drug development experience (at least 7 years in regulatory).
Required Skills/Experience:
- Independent delivery aligned with leadership; scientific knowledge; effective communication; worldwide regulatory agency familiarity.
- Success securing original NDA/BLA approvals.
- Strong interpersonal/negotiation skills; leadership experience building high-performing teams.
Preferred:
- Retinal disease/ophthalmology regulatory experience; people management.
- Experience across small/large molecule programs.
- Extensive U.S./international regulatory experience; prior Global Regulatory Lead experience.
Additional:
- Travel: 10%; Geographical scope: U.S. and global regulatory responsibility.
- Benefits: medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days; annual bonus and long-term incentive (if applicable).
Apply: https://jobs.merck.com/us/en (or Workday Jobs Hub). Requisition ID: R391555.