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Regulatory Affairs Manager in Lavaltrie, Quebec, CA at Vetoquinol Canada  

Date Posted: 7/10/2018

Job Snapshot

Job Description

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