Director, Regulatory Affairs – Fractional

Job Description

• Bring both strategic leadership and hands-on execution experience across the FDA regulatory landscape
• Navigate regulatory pathways and interactions across all three FDA medical product centers: CDER, CBER, CDRH

Requirements

• Extensive ophthalmology regulatory experience
• Proven FDA submission and agency interaction expertise
• Ability to develop regulatory strategy while driving tactical execution
• Experience supporting product development from early-stage through commercialization
• Strong cross-functional collaboration and leadership skills
• International regulatory affairs experience supporting product development and commercialization outside the U.S. (highly desirable)
• Familiarity with regulatory frameworks and health authority interactions in Europe/UK, Latin America, Japan, Australia, and broader APAC markets, including China (highly desirable)
• Experience developing global regulatory strategies and coordinating submissions across multiple jurisdictions (highly desirable)

Benefits