Senior/Vice President of Regulatory Affairs and ...

Join Parexel, a leader in drug development that shapes the future of healthcare. As the Senior/Vice President of Regulatory Affairs and Strategy in our Regulatory Strategy (RS) team, you will play a pivotal role in guiding biopharma companies through intricate regulatory landscapes, ensuring the delivery of safer and more effective therapies to patients globally. In this exciting and influential position, you will: Direct strategic regulatory initiatives across a variety of product types and international markets Provide expert advice to clients throughout the product lifecycle, from early phases of development to post-marketing Utilize your scientific, technical, and commercial knowledge to impact regulatory results positively Lead and collaborate with teams comprised of distinguished subject matter experts Serve as a prominent representative of Parexel and a thought leader in the industry Embrace familiarity with evolving scenarios and showcase your passion for science, innovation, and public health. If you are dedicated to enhancing public health and making a significant impact, this is the opportunity for you! We are on the lookout for an exceptional Clinical Regulatory Leader with a deep understanding of clinical trial design and drug development to join our esteemed Regulatory Strategy team. The ideal candidate will be an internationally recognized expert with a track record of success and high-level relationships within client organizations. You will possess a comprehensive knowledge of our consulting methodologies and an in-depth understanding of the services offered by RS. In addition, you will mentor and support other RS personnel, contributing to the development of innovative services and techniques. Key Responsibilities: Project Execution: Collaborate or operate independently depending on project requirements. Lead problem-solving efforts, prioritize tasks, and maximize opportunities to enhance project performance and outcomes. Thought Leadership: Speak at industry conferences, write articles, and engage with professional organizations as an authority in your area of expertise. Consulting and Relationship Management: Offer technical and business consulting, act as a trusted advisor, and create solutions tailored to client specifications. Requirements: Education: MD degree required. Experience: Over 15 years in Clinical Development/Clinical Trial Design with substantial regulatory insight. Prior experience with a regulatory agency (e.g., FDA or MHRA) is critical. In-depth expertise in Endocrinology, Neuroscience, Rare Disease, or Immunology. Willingness to travel 20-30% of the time, both domestically and internationally, for client engagements and conferences. Parexel is an equal opportunity employer. All qualified applicants will receive consideration for employment regardless of legally protected status.

Created: 2026-03-11