Senior/Vice President of Regulatory Strategy
PAREXEL - Raleigh, NC
Apply NowJob Description
Join Parexel, a leader in drug development that shapes the future of healthcare. As the Senior/Vice President of Regulatory Strategy on our Regulatory Strategy (RS) team, you will play a crucial role in guiding biopharma companies through complex regulatory landscapes, ensuring the delivery of safer and more effective therapies to patients worldwide. In this dynamic and influential role, you will: Direct strategic regulatory initiatives across a range of product types and international markets. Provide expert guidance to clients throughout the product lifecycle, from initial development to post-marketing. Leverage your scientific, technical, and commercial knowledge to enhance regulatory outcomes. Lead and collaborate with esteemed subject matter experts in various fields. Represent Parexel as a prominent thought leader in the industry. Demonstrate your passion for science, innovation, and public health by adapting to evolving scenarios. If you are committed to improving public health and want to make a profound impact, this is the opportunity for you! We seek an exceptional Clinical Regulatory Leader with extensive knowledge of clinical trial design and drug development to join our distinguished Regulatory Strategy team. The ideal candidate will be recognized internationally with a proven track record and strong relationships within client organizations. You will possess an in-depth understanding of our consulting methodologies and the services provided by RS. Additionally, you will mentor and support other RS personnel, contributing to the development of innovative services and techniques. Key Responsibilities: Project Execution: Collaborate or work independently based on project needs. Drive problem-solving efforts, prioritize tasks, and capitalize on opportunities to improve project performance and outcomes. Thought Leadership: Speak at industry conferences, publish articles, and engage with professional organizations as a recognized authority in your area of expertise. Consulting and Relationship Management: Provide technical and business consulting, serve as a trusted advisor, and create tailored solutions for clients. Requirements: Education: MD degree required. Experience: Minimum of 15 years in Clinical Development/Clinical Trial Design with profound regulatory insight. Previous experience with a regulatory agency (e.g., FDA or MHRA) is essential. Expertise in Endocrinology, Neuroscience, Rare Disease, or Immunology is highly preferred. 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: 2026-03-10