Regulatory Affairs Associate (2)

Brossard, Canada. 23 December, 2022

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. The candidates will report to the Regulatory Affairs Senior Manager.

 

Responsibilities

 

  • Prepare and/or review:
    • Administrative and Cross-Reference submissions for DIN products;
    • NPN applications (notifications, amendments), within targeted timelines;
    • Review, update and approve the labels for prescription drugs, over the counter (OTC) and Natural Health Product (NHP) and include fact sheet table when applicable;
    • Evaluate and prepare submissions related to product monograph updates, when applicable;
    • Support the team in the preparation of Module 1 documentation for ANDS including:
      • Regulatory enrolment process (REP);
      • Product information (PI);
      • Regulatory transaction (RT);
      • Cover Letter.
      • Support the team for the preparation and filing of various types of regulatory submissions (ANDS, SANDS, DINA);
      • Assemble and compile regulatory files in eCTD format:
        • Upload files in eCTD software;
        • Publish (convert to PDF, bookmarks, hyperlinks);
        • Submit eCTD submissions to Health Canada.
        • Provide support with day-to-day departmental activities as required;
        • Ensure that the various internal databases, archiving and post-approval activities related to regulatory submissions are maintained according to the department’s procedures;
        • Complete other Regulatory Affairs duties as required to ensure compliance with Canadian requirements and the achievement of applicable projects and objectives.

         

        Qualifications

         

        • Bachelor’s in science (chemistry, biology, biochemistry or relevant related field);
        • 1 to 3 years in the regulatory field within the pharmaceutical industry;
        • Bilingualism French/English (written and spoken) to exchange with colleagues in Ontario and Brossard and with partners outside Quebec;
        • Computer literacy with MS Office and Adobe Acrobat;
        • Knowledge of the Canadian Regulatory Framework for pharmaceutical products.

         

        Applicant’s profile

        • Problem solving ability and innovative creative thinking;
        • Keen detail orientation to identify errors;
        • Writing skills, and ability to review and provide improvement to regulatory documents;
        • Team player, thoroughness.
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        Candidature EN
        Maximum upload size: 104.86MB

        Other job offers available

        Regulatory Affairs Associate (2)

        Emplacement: Brossard, Canada

        Apply now

        Candidature EN
        Maximum upload size: 104.86MB

        Other job offers available

        Regulatory Affairs Associate (2)

        Emplacement: Brossard, Canada