R0000030967 Senior / Vice President, Technical – Clinical Regulatory Affairs (home-based)

Parexel is hiring a Senior Vice President, Technical in Clinical Regulatory Affairs to drive regulatory strategy and leadership in Frankfort, Kentucky. This full-time position enables you to influence how leading biopharma organizations navigate clinical development and bring new medicines to patients.

About the Role

In this leadership role, you'll combine deep regulatory expertise with strategic advisory capabilities to guide clients through complex clinical development landscapes. As Senior / Vice President, Technical in Clinical Regulatory Affairs, you'll shape regulatory pathways, support submissions, and lead strategic client relationships at the executive level.

What You'll Do

• Develop regulatory strategies and clinical development roadmaps for diverse therapeutic programs
• Advise biopharma clients on FDA interactions and regulatory pathways
• Prepare and manage regulatory submissions, including INDs, NDAs, and BLAs
• Design clinical protocols and programs with regulatory requirements in mind
• Lead regulatory teams and mentor junior regulatory professionals
• Engage with clients at the C-suite level to align regulatory strategy with business objectives
• Support clinical trial design, safety monitoring, and compliance activities

What We're Looking For

• Extensive clinical regulatory affairs experience, including time in senior management roles
• In-depth knowledge of FDA regulations, guidance documents, and international regulatory standards
• Demonstrated experience leading regulatory teams and managing complex clinical development programs
• Strong executive-level communication and client relationship management skills
• Proven ability to develop comprehensive regulatory strategies
• Advanced degree in pharmaceutical sciences, chemistry, biology, or related discipline

About Parexel

Parexel is a premier contract research organization supporting biopharma innovation. Our teams help clients optimize their development strategies and navigate regulatory requirements to bring effective treatments to market faster. We're committed to advancing science and supporting regulatory success.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.