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Expect scenarios on agency interactions, technical regulatory writing for complex trials, and how a CRO balances sponsor goals with compliance. Prepare examples of high-stakes decisions under tight timelines.
Strong fit if you already lead clinical regulatory strategy at scale and want a home-based technical VP seat inside a major CRO serving drug developers.
As Senior / Vice President, Technical – Clinical Regulatory Affairs at Parexel, the day centers on regulatory strategy for client trials: aligning submissions and technical positions with global health authorities, advising study teams on compliance risk, and coordinating with clinical, medical, and quality partners so development programs stay inspection-ready.
Deepen ICH/GCP and multi-region submission fluency; strengthen leadership of cross-functional regulatory positions. Free learning options:
It is a contract research organization that conducts clinical trials for pharmaceutical and biotechnology clients.
The title lists the position as home-based; the posting also shows a Wyoming, Kent County, Michigan location context.
DATA lists Parexel as founded in 1982.
Website: parexel.com
Parexel is an American contract research organization. It conducts clinical trials on behalf of its pharmaceutical and biotechnology clients to expedite drug development and clinical trial progress.
Public cache only — not an employee review.
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.
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