Regulatory affairs manager

July 10 2018
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs
Lavaltrie, QC

Are you looking for a company that has the well-being of its employees at heart and continually invests in the development of its employees? If so, look no further! Vetoquinol is a Great Place To Work and an employer who believes that we Achieve more together!This pharmaceutical company dedicated to manufacturing, distributing and commercializing animal health products is looking for a Regulatory Affairs Manager.

Your main mission will be to ensure that current and future Vetoquinol products are approved, distributed / sold and controlled (pharmacovigilance) in accordance with Canadian regulations.

Vetoquinol Product Registration Records Management

  • Updates registrations of veterinary products on the Canadian market.
  • Helps bring new products to market through Canadian regulatory expertise.
  • Participates in the development of registration plans.
  • Prepares and tracks registration dossiers with regulatory authorities until market authorization is obtained.
  • Ensures and coordinates the life-cycle management of Canadian products registered abroad.

Regulatory conformity

  • Ensures the application of regulations and the preparation of documents for products sold in Canada.
  • Ensures the retention of Establishment Licenses for veterinary drugs.
  • Ensures compliance with environmental regulations.
  • Participate to the recall of pharmaceutical products from the market.

Other important missions

  • Provides external representation and influences Canadian regulations.
  • Ensures the coordination and reporting of pharmacovigilance cases in Canada.
  • Ensures the conformity of activities and promotional material in relation to the regulations in force.
  • Participates in the development of clinical and preclinical trials to obtain marketing authorization in Canada.

JOB REQUIREMENTS

  • University degree in veterinary medicine or pharmacy, or a degree in science combined with related experience in regulatory affairs
  • Excellent knowledge of Canadian regulations
  • Minimum of 3 year experience in the field
  • Bilingual, French and English (oral and written)
  • Functional computer knowledge in Windows environment (Word, Excel, PowerPoint, Outlook)
  • Autonomous
  • Positive interpersonal skills / Communication skills
  • Sense of organization
  • Ability to analyze and solve problems
  • Teamwork
Apply now!

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