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Regulatory Affairs Specialist

2 months ago

Markham, Ontario, Canada Kelly Science, Engineering, Technology & Telecom Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Associate to join our team at Kelly Science, Engineering, Technology & Telecom. As a Regulatory Affairs Associate, you will play a critical role in ensuring compliance with regulatory requirements for our pharmaceutical and medical device clients.

Key Responsibilities
  • Coordinate the preparation and review of regulatory submissions for pharmaceutical and medical device products.
  • Prepare and submit applications to obtain product licenses for Canada, including cosmetic, medical device, natural health product, and non-prescription drug applications.
  • Collaborate with manufacturing, Quality Assurance, Graphics, Supply Chain, and Marketing teams to ensure timely assessment and approval of new products and changes to marketed products.
  • Review and approve labeling, promotional materials, and other communications for pharmaceutical and medical device products to ensure compliance with Health Canada regulations.
  • Maintain up-to-date information on Health Canada requirements to ensure timely review and approval of product submissions.
  • Represent the Regulatory Affairs department on assigned project teams.
  • Manage the archiving of regulatory submissions to ensure ease of retrieval.
  • Support audits by Health Canada and other regulatory agencies.
Requirements
  • Bachelor's degree in science or a related field.
  • At least 5 years of experience in regulatory affairs, with a minimum of 2 years of experience in Canadian regulatory affairs for pharmaceuticals and/or medical devices.
  • Strong knowledge of review and approval of promotional materials and artwork.
  • Working knowledge of Health Canada laws and regulations for OTC, NHPs, and cosmetics.
  • Experience with Plain Language Labelling for OTC and NHP is an asset.
  • Proficiency in Microsoft Word and other common software tools.
  • Ability to handle confidential information and materials in an appropriate manner.
  • Excellent communication, interpersonal, and organizational/time management skills.
  • Ability to function effectively with minimum supervision.