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Be ready to walk a complex submission decision, how you set technical standards, and how you partner with clinical ops under timelines. Expect scenario questions on agency feedback, risk tradeoffs, and leading senior specialists.
Best for seasoned regulatory technical leaders who can own strategy in a CRO serving pharma/biotech—less ideal if you want pure bench science or early-career IC work.
As Senior/Vice President, Technical – Clinical Regulatory Affairs at Parexel, expect leadership over strategy for trial and product submissions: guidance on global regulatory pathways, quality of dossiers, cross-functional work with clinical, medical writing, and client teams, and escalation on high-stakes agency interactions.
Build domain depth in ICH/FDA/EMA pathways and dossier leadership. Low-cost refreshers from CERTS:
The title says home-based; listing remote flag is 0 and location is Frankfort, KY—confirm work model with Parexel.
It is a CRO that runs clinical trials for pharma and biotech clients to advance drug development.
DATA does not list required certs; free health-science study options include Saylor and Coursera audit tracks if you want structured refreshers.
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 hiring a Senior Vice President, Technical in Clinical Regulatory Affairs to drive regulatory strategy and leadership in Frankfort, Franklin County. This full-time position enables you to influence how leading biopharma organizations navigate clinical development and bring new medicines to patients. About the Role In this leadership role, you'll combine deep regulatory expertise with strategic advisory capabilities to guide clients through complex clinical development landscapes. As Senior / Vice President, Technical in Clinical Regulatory Affairs, you'll shape regulatory pathways, support submissions, and lead strategic client relationships at the executive level. What You'll Do Develop regulatory strategies and clinical development roadmaps for diverse therapeutic programs Advise biopharma clients on FDA interactions and regulatory pathways Prepare and manage regulatory submissions, including INDs, NDAs, and BLAs Design clinical protocols and programs with regulatory requirements in mind Lead regulatory teams and mentor junior regulatory professionals Engage with clients at the C-suite level to align regulatory strategy with business objectives Support clinical trial design, safety monitoring, and compliance activities What We're Looking For Extensive clinical regulatory affairs experience, including time in senior management roles In-depth knowledge of FDA regulations, guidance documents, and international regulatory standards Demonstrated experience leading regulatory teams and managing complex clinical development programs Strong executive-level communication and client relationship management skills Proven ability to develop comprehensive regulatory strategies Advanced degree in pharmaceutical sciences, chemistry, biology, or related discipline About Parexel Parexel is a premier contract research organization supporting biopharma innovation. Our teams help clients optimize their development strategies and navigate regulatory requirements to bring effective treatments to market faster. We're committed to advancing science and supporting regulatory success. How to Apply To apply for this Senior / Vice President, Technical position in Clinical Regulatory Affairs at Parexel in Frankfort, Franklin County, submit your application through this listing.
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