Lead Clinical and Regulatory Affairs Professional

1 day ago


Richmond Hill, Ontario, Canada Brunel International Full time
Job Summary

Brunel International is seeking an experienced Lead Clinical and Regulatory Affairs Professional to join our team. The successful candidate will be responsible for ensuring compliance with regulations, managing clinical trials, and evaluating investigational sites in North America.

Main Responsibilities
  • Assist in the planning, management, and execution of clinical trials in the pharmaceutical or medical device industry.
  • Evaluate investigational sites in North America to ensure they meet regulatory requirements.
  • Maintain the Trial Master File throughout the study, collaborating with external vendors as required.
  • Secure IRB study approvals and assist with sites' IRB submissions and approvals.
  • Support business development efforts by building relationships with industry professionals, clinicians, and investigators.
Requirements
  • University degree or Masters in a scientific field.
  • Minimum 3-5 years of experience in clinical and medical affairs management.
  • Bilingual (English and French) would be preferred but not officially required.
  • Track record of completed clinical trials from conception to publication.
  • Experience in medical affairs activities, such as advisory boards and educational programs development.
Estimated Salary: $90,000 - $120,000 per year

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