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Senior Vice President of Regulatory Affairs

PAREXEL - Madison, WI

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Job Description

Join Parexel, a leading name in drug development that is dedicated to transforming the future of healthcare. As the Senior Vice President of Regulatory Affairs on our Regulatory Strategy (RS) team, you will have the opportunity to play a pivotal role in navigating biopharma companies through intricate regulatory environments, ensuring that safer and more effective therapies reach patients globally. In this exciting and impactful position, you will: Lead strategic regulatory initiatives encompassing diverse product types and global markets. Offer expert guidance to clients throughout the comprehensive product lifecycle, from initial development through to post-marketing. Utilize your scientific, technical, and commercial expertise to improve regulatory outcomes. Collaborate with esteemed subject matter experts across various domains. Serve as a distinguished thought leader representing Parexel in the industry. Exhibit your dedication to science, innovation, and public health by embracing evolving scenarios. If you are passionate about enhancing public health and making a significant impact, this is the opportunity for you! We are looking for an outstanding Clinical Regulatory Leader who has extensive knowledge in clinical trial design and drug development to join our renowned Regulatory Strategy team. The ideal candidate will be recognized globally with a proven track record and solid relationships within client organizations. You will have a deep understanding of our consulting methodologies and the range of services offered by RS. Furthermore, you will mentor and support other RS team members, aiding in the development of innovative services and techniques. Key Responsibilities: Project Execution: Work collaboratively or independently depending on project needs. Lead problem-solving initiatives, prioritize tasks effectively, and seize opportunities to enhance project performance and outcomes. Thought Leadership: Present at industry conferences, publish thought-provoking articles, and engage actively with professional organizations as a recognized authority in your specialization. Consulting and Relationship Management: Provide technical and business consulting, act as a trusted advisor, and develop customized solutions for clients. Requirements: Education: MD degree required. Experience: A minimum of 15 years in Clinical Development/Clinical Trial Design with extensive regulatory insight. Previous experience with a regulatory agency (e.g., FDA or MHRA) is mandatory. Expertise in Endocrinology, Neuroscience, Rare Disease, or Immunology is strongly 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 be considered for employment without regard to legally protected status.

Created: 2026-03-12

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