Regulatory Affairs Specialist

• 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.