Director, Regulatory Affairs (Fractional)

Lexitas

3d • $300 - $350

About The Position

Lexitas is searching for a Fractional Director of Regulatory affairs to bring both strategic leadership and hands-on execution experience across the FDA regulatory landscape, with deep expertise in ophthalmic products. This individual should have demonstrated success navigating regulatory pathways and interactions across all three FDA medical product centers: CDER (Center for Drug Evaluation and Research), CBER (Center for Biologics Evaluation and Research), and CDRH (Center for Devices and Radiological Health).

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

Nice To Haves

• International regulatory affairs experience supporting product development and commercialization outside the U.S.
• Familiarity with regulatory frameworks and health authority interactions in Europe/UK, Latin America, Japan, Australia, and broader APAC markets, including China
• Experience developing global regulatory strategies and coordinating submissions across multiple jurisdictions

Responsibilities

• Bring strategic leadership and hands-on execution experience across the FDA regulatory landscape, with deep expertise in ophthalmic products.
• Navigate regulatory pathways and interactions across all three FDA medical product centers: CDER, CBER, and CDRH.
• Develop regulatory strategy while driving tactical execution.
• Support product development from early-stage through commercialization.
• Collaborate cross-functionally and provide leadership.

What This Job Offers

• Career Level: Director
• Education Level: No Education Listed