Associate Project Manager Regulatory Affairs - Brossard

Posted on June 27, 2025

Associate Project Manager Regulatory Affairs – Brossard

Scientific Affairs

Benefits and job description Qualifications and Applicant's profile Avantages

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Benefits and job description

Why join us?

Hybrid position with a flexible schedule;
Regular, full-time position;
Group insurance, including telemedicine and a health spending account;
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 Associate Project Manager Regulatory Affairs will participate in the preparation and submission of various regulatory documents to ensure timely approval and regulatory maintenance/compliance of the product portfolio (DIN and NHP) in accordance with applicable laws, regulatory guidelines and policies.

Main tasks and responsibilities

Registration of generic pharmaceutical products and Natural Health Products according to the Health Canada Standards and predefined timelines, involving:
- Planning, preparation and submission of documents/applications;
- Critical assessment of scientific data and gap analysis for Module 2 and Module 3 to meet Canadian requirements;
- Responses to clarification request within deadlines set by Health Canada;

Maintain the regulatory compliance for approved/marketed products on the Canadian market, in compliance with the Food and Drugs Act, its Regulations, and all relevant Canadian guidelines;
Ensure the management of aspects related to the development of product label content;
Participate in the development and implementation of regulatory strategies;
Negotiate and create efficient bonds with Health Canada (pre-submission meetings, Clarifax, etc.);
Ensure follow-ups and updates of various databases and post-approval activities related to regulatory documents;
Participation in due diligence activities;
Effectively conduct follow-ups with corporate partners;
Participate in the regulatory reviews of other departments;
Compile and develop regulatory files (submissions, responses…), in eCTD format:
- Uploading files in eCTD software;
- Publishing in eCTD format;
- Submitting through CESG;

Perform other related tasks required by the manager.

Qualifications and Applicant's profile

Master’s degree in life sciences (chemistry, biology, biotechnology) or other relevant fields;
Minimum of 5 years of experience in a regulatory position within the generic pharmaceutical industry;
Excellent oral and written communication skills in French and English (to interact with partners and employees outside Quebec and to send submissions to Health Canada);
Proficiency in Microsoft Office, Adobe and ERP systems;
Strong analytical skills in CMC and clinical aspects;
Excellent knowledge of Canadian regulations and ability to interpret policies and guidelines;
Strong technical writing skills, ability to evaluate and critique regulatory documents;
Detail-oriented with strong analytical and organizational skills;
Ability to work effectively in a team and manage multiple projects simultaneously;
Ability to perform under pressure and meet tight deadlines.