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

Join Parexel as a Senior / Vice President, Technical in Clinical Regulatory Affairs, based in Phoenix, Maricopa County. Lead technical strategy and regulatory excellence for innovative biopharmaceutical clients seeking to bring life-changing therapies to market faster and more effectively.

About the Role

As a Senior / Vice President, Technical in Clinical Regulatory Affairs at Parexel, you'll partner directly with leading biopharma organizations to shape the regulatory and clinical development strategies that determine how therapies advance through the healthcare landscape. Your expertise will help clients navigate complex regulatory environments, accelerate their timelines, and ultimately bring critical medicines to patients who need them. This is a high-impact leadership position where strategic thinking, deep technical knowledge, and client partnership drive measurable results.

What You'll Do

• Develop and execute comprehensive technical regulatory strategies for clinical and regulatory programs across multiple therapeutic areas
• Serve as a trusted strategic advisor to senior leadership at biopharma companies, translating complex regulatory pathways into actionable plans
• Lead technical teams in preparing regulatory submissions, including INDs, NDAs, BLAs, and other critical filings
• Guide clients through FDA interactions, advisory meetings, and inspection preparation with authority and insight
• Identify regulatory risks and opportunities early in development, helping clients make informed strategic decisions
• Collaborate across Parexel's multidisciplinary network to deliver integrated solutions that combine regulatory science, clinical operations, and technical excellence

What We're Looking For

• Extensive experience in clinical regulatory affairs, ideally with prior FDA background or equivalent regulatory agency exposure
• Deep technical knowledge of drug development processes, regulatory frameworks, and clinical trial design
• Proven success in a senior leadership or consulting role, managing complex programs and leading teams
• Strong communication skills with the ability to influence and advise senior executives
• Strategic mindset combined with attention to scientific and regulatory detail
• Track record of helping clients accelerate development timelines while maintaining compliance and quality

About Parexel

Parexel is a leading biopharmaceutical services organization dedicated to supporting the development of innovative therapies that transform patient outcomes. With deep expertise across clinical regulatory affairs, clinical operations, and strategic consulting, Parexel partners with biopharma companies at every stage of the development journey. Our team includes former FDA colleagues and industry veterans who bring real-world regulatory insight and operational excellence to every engagement.

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.