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Regulatory Affairs Specialist

4 months ago

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

  • Under the responsibility of the VP Compliance and General Manager, the
    Regulatory Affairs specialist will be responsible for developing, facilitating and
    execute comprehensive regulatory strategies through all phases of
    product development and life cycle, accelerate and ensure
    successful product registrations for product launches and management
    changes for marketed products.

  • 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.