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Parexel

Senior Vice President, Technical - Clinical Regulatory Affairs

Parexel

Senior/Vice President, Technical overseeing regulatory strategies for biopharma clinical development. Work from home position with significant impact on patient therapeutic developments.

Posted 6/20/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact
  • Work on a variety of assignments, diverse product types for clients
  • Creating opportunity for clients throughout the product lifecycle
  • Sharing scientific, technical, regulatory, and/or commercial expertise
  • Leading teams of respected SMEs
  • Meeting new situations and learning
  • Provide mentoring and guidance to other RS employees

Requirements

What you’ll need
  • MD or PhD required
  • 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 is strongly preferred
  • 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

Benefits

Comp & perks
  • Work from home
  • Opportunity to influence development strategies

ATS Keywords

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Hard Skills & Tools
Clinical DevelopmentClinical Trial DesignClinical StrategyRegulatory ApplicationsNeuroscienceRare DiseaseImmunologyEndocrinologyMedical ReviewTeam Leadership
Soft Skills
MentoringGuidanceLearning AgilityTeam LeadershipCommunication
Certifications
MDPhD