Regulatory Affairs Manager

4 weeks ago

Farnham QC JJ, Brome-Missisquoi, Canada Cannara Biotech inc Full time

General Summary

  • Manage licensing and communications with Health Canada;
  • Provide regulatory requirements expertise to other departments during
    product development or proposed product changes
    approved (including R&D, manufacturing, quality assurance, quality control and
    marketing);
  • Research and analyze regulatory information and determine acceptability of
    product data, procedures and other documentation submitted in support of
    Product registration;
  • Prepare, review, analyze and consolidate all information required for
    initial or post-approval regulatory submissions to competent authorities, y
    including Health Canada;
  • Write related technical parts of the detailed summaries that are included in the
    submission filed with regulatory authorities;
  • Ensure compliance with government regulations by providing agencies
    all necessary information relating to the changes or
    changes to the company’s products;
  • Review technical and clinical literature and recommend changes
    in labelling, manufacturing and marketing protocols to ensure and
    maintain regulatory compliance;
  • Prepare, in accordance with the required deadlines, requests for amendments to be submitted to regulatory agencies for approved products;
  • Review/revise promotional materials and product label components to ensure regulatory compliance;
  • Liaise with Quality and Compliance and business partners to consolidate relevant technical documents for each product file;
  • Provide support for authority inspections;
  • Oversee updates to printed materials (labels, boxes, bags, etc.).

Qualifications

  • Have a BSc or equivalent education;
  • Have a minimum of three (3) years of relevant cannabis and/or pharmaceutical experience;
  • Proficiency with Microsoft Office software (Word, Excel and Outlook);
  • Excellent writing and communication skills in both English and French;
  • Strong analytical skills and ability to anticipate problem situations;
  • Ability to understand and interpret regulatory texts;
  • Demonstrate a sense of responsibility, organization and planning;
  • Interpersonal skills, diplomacy and initiative;
  • Demonstrate teamwork;
  • Ability to work independently or as part of a team in a timely manner;
  • Security clearance in the cannabis industry is an asset.

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