R0000030967 Senior / Vice President, Technical - Clinical Regulatory Affairs (home-based)
RemoteUnited States
Job Summary
Senior / Vice President, Technical on Parexel’s Regulatory Strategy team (RS) leading regulatory strategy and thought leadership for clinical development programs. Responsible for mentoring SMEs, guiding project execution, and delivering high-impact regulatory consulting services across multiple disciplines, with extensive interactions with clients and health authorities. Role emphasizes leadership, strategic thinking, and internationally recognized expertise in regulatory affairs, clinical trial design, and drug development, while supporting work-from-home arrangements in the United States. Travel up to 20-30% may be required for client meetings and conferences.
Required Qualifications
- Education - MD or PhD required
- Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications
- Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc. or a related Medical role i.e. Clinical Pharmacology Review is strongly preferred, but SMEs with Industry experience will also be considered
- Extensive Neuroscience, Rare Disease, Immunology, Endocrinology/Metabolism experience is highly preferred
- Ability to travel up to 20-30% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance
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