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

Parexel is seeking a Senior / Vice President, Technical specializing in Clinical Regulatory Affairs to join our team in Wyoming, Kent County. This is a full-time leadership position where you'll shape regulatory strategy for pioneering biopharma companies navigating the complex path from research to market access.

About the Role

As Senior / Vice President of Technical Clinical Regulatory Affairs at Parexel, you'll lead high-impact regulatory initiatives that accelerate the development of life-changing therapies. You'll partner directly with biopharmaceutical clients to design compliant development pathways, anticipate regulatory challenges, and drive strategic engagement with health authorities including the FDA.

What You'll Do

• Develop and execute clinical regulatory strategies for novel drug and device programs across multiple therapeutic areas
• Lead regulatory affairs teams and serve as principal technical expert on client-facing consulting engagements
• Guide clinical programs through IND applications, NDA/BLA submissions, and post-market compliance requirements
• Provide strategic counsel on regulatory risk assessment, mitigation approaches, and health authority interactions
• Build regulatory frameworks that balance innovation velocity with rigorous safety and efficacy standards
• Mentor junior regulatory specialists and contribute to organizational thought leadership in clinical regulatory affairs

What We're Looking For

• Extensive professional experience in clinical regulatory affairs, ideally including FDA background or comparable health authority expertise
• Proven track record leading regulatory strategy for drug or medical device development programs
• Deep command of IND, NDA/BLA, 505(b)(2), and specialized regulatory pathways
• Demonstrated ability to influence senior client stakeholders and navigate complex regulatory negotiations
• Strong writing and presentation skills for regulatory submissions, strategy documents, and executive communications
• Master's degree in pharmacy, chemistry, biological sciences, or related discipline (or equivalent professional credentials)

About Parexel

Parexel is a global clinical regulatory consulting leader, partnering with innovative biopharma companies to advance therapies that transform patient outcomes. We combine deep technical expertise with collaborative client partnerships that accelerate drug development and bring important treatments to market faster.

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.