Executive Director, Regulatory Affairs Liaison

About the role

The Executive Director, Regulatory Affairs Liaison leads global regulatory strategy for ophthalmology and retinal disease programs within General Medicine. Reporting to the VP of General Medicine, this senior leader ensures alignment of regulatory objectives with development, evidence generation, and commercialization priorities.

Key responsibilities

• Define and execute global regulatory strategy for multiple ophthalmology indications to accelerate approvals and optimize labeling.
• Provide oversight and mentorship to Global Regulatory Leads, ensuring they serve as single points of accountability for assigned projects.
• Review and approve key regulatory deliverables, including submissions, press releases, background packages, study protocols, and labeling.
• Represent the company at external regulatory authority meetings, enterprise governance bodies, and internal committees.
• Contribute strategic input to regulatory due‑diligence activities for licensing candidates.

Required profile

• B.S./M.S. in a biological science with at least 12 years of drug development experience, majority in regulatory affairs, or M.D./Ph.D./PharmD. with at least 9 years experience and 7 years in regulatory.
• Proven track record of securing original NDA/BLA approvals.
• Strong scientific knowledge and familiarity with worldwide regulatory agencies.
• Outstanding interpersonal, communication, and negotiation abilities.
• Leadership experience building and managing high‑performing teams.

Required skills

• Regulatory strategy development
• Global regulatory affairs
• Ophthalmology and retinal disease program expertise
• People management
• Experience with both small‑ and large‑molecule development

What we offer

• Salary range $231,900 – $365,000 per year
• Annual bonus and long‑term incentive eligibility
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays and vacation