Specialist, Regulatory Affairs

Vetoquinol N-A Inc•Lavaltrie, QC

21d•Hybrid

About The Position

Are you looking to join a company that places employee well‑being at the heart of its priorities and continuously invests in developing the potential of its team? Vetoquinol is the employer of choice you will enjoy collaborating and innovating with. As a pharmaceutical company specializing in the manufacturing, distribution, and commercialization of veterinary health products, we are looking for a Regulatory Affairs Specialist to join our team. Ensure the submission of marketing authorization applications and amendments in accordance with the quality, efficacy, and safety requirements for veterinary drugs. Ensure the preparation of labels and package inserts for veterinary products. Ensure the maintenance of licenses. Prepare declarations, reports, and other documents necessary for the company’s regulatory compliance. Ensure the compliance of marketing materials.

Requirements

Bachelor’s degree in life sciences (pharmacology, biopharmaceutical science, biochemistry, or a related field)
3 to 5 years of experience in regulatory affairs within the pharmaceutical industry
Experience in animal health
Knowledge of drug quality, efficacy, and safety
Strong oral and written communication skills
Excellent proficiency in Microsoft Office software
Knowledge of federal and provincial regulatory requirements
Bilingualism in French and English (spoken and written)
Analytical and critical thinking skills
Attention to detail
Diligence
Occasional business travel (national business meetings or other meetings related to business needs).
This role requires ongoing communication and collaboration with French and English speakers across Canada and/or internationally. In order to fully meet the language requirements and ensure effective management of interactions, proficiency in French and English is essential.

Responsibilities

Preparation of labels and package inserts for veterinary products
Drafting text to be included in accordance with the marketing authorization.
For any new creation or modification of products sold in Canada by Vetoquinol N.A. Inc., and in collaboration with other reviewers and suppliers: Ensure initiation and follow-up in accordance with established procedures.
Review and approve labels and package inserts to ensure regulatory compliance.
Use the computer-based artwork management system.
Prepare marketing authorization application and amendment dossiers.
Prepare responses to regulatory authorities.
Participate in assessing the regulatory impact of product changes.
Carry out the steps assigned to them in change controls.
Ensure regulatory data governance in accordance with established procedures.
Respond to requests from the Vetoquinol Group regarding documents from Canadian regulatory authorities and products sold in Canada to support foreign registrations.
Prepare the required data reports for management organizations or regulatory authorities (extended producer responsibility: recycling of packaging and printed materials, collection of unused medications, plastics; antimicrobials, sales, and others.)
Complete and submit, within the required deadlines, the documents for the annual review or amendments to the establishment license.
Maintain evidence of compliance with Good Manufacturing Practices (GMP) at foreign sites.
Complete and submit to provincial and/or federal authorities the documents required to obtain or maintain the mandatory licenses and/or permits for the sale and distribution of various products, as well as import and export declarations for regulated products.
Establish, draft, and update procedures and forms related to their activities.
Ensure that promotional activities and materials developed for Vetoquinol’s clients in Canada comply with applicable regulations as well as the ICSA’s “Code of Marketing Practices.”
Coordinate the creation and updating of Safety Data Sheets (SDS) for products sold by Vetoquinol N.A. Inc. in accordance with the current procedure.
Respond to customer inquiries regarding SDSs in accordance with regulations.