Regulatory Affairs Specialist - Part time

General Summary

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.

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.).