Regulatory Compliance Coordinator

7 days 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 be responsible for 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.
  • Work with cross-functional teams to enable timely assessment and approval of new products and changes to marketed products.
  • Review and approve labeling, promotional materials, and other communications for compliance with Health Canada Regulations.
  • Maintain up-to-date information regarding Health Canada requirements.
  • Represent the Regulatory Affairs department on project teams.
  • Manage the archiving of regulatory submissions.
  • Support audits by Health Canada and other regulatory agencies.
Requirements
  • Bachelor's degree in science or related field.
  • Overall 5 years of thorough regulatory affairs experience, with minimum 2-3 years of Canadian Regulatory Affairs experience in pharmaceuticals and/or medical devices.
  • Strong knowledge of review and approval of promotional materials and artwork.
  • Working knowledge of Health Canada laws and regulations.
  • Experience with Plain Language Labelling for OTC and NHP is an asset.
  • Proficient with Microsoft Word and other common software tools.
  • Ability to handle confidential information and materials.
  • Excellent communication, interpersonal, and organizational/time management skills.

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