Director, Regulatory Affairs – Fractional

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide both strategic direction and practical execution expertise within the FDA regulatory environment.

• Manage regulatory pathways and communications across all three FDA medical product divisions: CDER, CBER, and CDRH.

⛳️ Requirements

• Significant regulatory experience in ophthalmology.

• Demonstrated expertise in FDA submissions and interactions with the agency.

• Capable of formulating regulatory strategies while ensuring effective tactical implementation.

• Experience in supporting product development from initial stages to commercialization.

• Strong skills in cross-functional collaboration and leadership.

• International regulatory affairs experience in product development and commercialization outside the U.S. (highly desirable).

• Knowledge of regulatory frameworks and health authority interactions in Europe/UK, Latin America, Japan, Australia, and the broader APAC region, including China (highly desirable).

• Experience in developing global regulatory strategies and managing submissions across various jurisdictions (highly desirable).

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and career advancement.

• A dynamic work environment that fosters innovation and collaboration.