Executive Director, Regulatory Affairs Liaison
Core
Define and execute global regulatory strategy for ophthalmology and retinal disease programs to minimize time to approval and optimize labeling.
Role type
Executive Director, Regulatory Affairs (Ophthalmology)
Builds
Global regulatory strategy, submissions, external communications, and local registration study protocols for ophthalmology drug development.
Domain
Pharmaceutical Regulatory Affairs / Ophthalmology
Required skills
Global regulatory strategy, NDA/BLA approval, team leadership, regulatory compliance, stakeholder engagement, resource allocation
Preferred skills
Retinal disease expertise, people management, small and large molecule development, US and international regulatory affairs
Technologies
None stated
Responsibilities
Oversee global regulatory strategy for ophthalmology programs; lead and develop a team of Global Regulatory Leads; review and approve key regulatory deliverables; represent the company at external regulatory authority meetings; provide strategic input into regulatory due diligence.
Seniority
Executive, strategic leadership & team management