Why join us?

• Hybrid position with a flexible schedule;
• Regular, full-time position;
• Group insurance, including telemedicine and a health spending account;
• 3 weeks’ vacation and paid time off during the holiday season;
• Group RSP with employer contribution;
• 4 sick days per year;
• Free indoor parking;
• Office near the DIX30 REM station;
• And much more!

Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Associate main responsibilities will be to support the labelling activities (labels and products monographs) of Regulatory Affairs department for products on the market.

Main tasks and responsibilities

• Prepare and/or review the administrative submissions for DIN products and NPN applications;
• Support the team in the preparation of Module 1 (Regulatory enrolment process, Product information, etc.);
• Assemble and compile regulatory files (submissions, answers) in eCTD format;
• Support the team for the preparation and filing of various types of regulatory submissions (ANDS, SANDS, DINA);
• Ensure that the various internal databases, archiving and post-approval activities related to regulatory submissions are maintained according to the department’s procedures;
• Provide support with day-to-day departmental activities as required;
• Review, update and approve the labels for prescription drugs, OTC and NHP and include fact sheet table when applicable;
• Evaluate and prepare submissions related to product monograph updates, when applicable;
• Complete other Regulatory Affairs duties as required to ensure compliance with Canadian requirements and the achievement of applicable projects and objectives.