Regulatory Compliance Associate

6 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 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 aesthetic and consumer business unit products.
  • Prepare and submit cosmetic, medical device, natural health product, and non-prescription drug applications to obtain product licenses for Canada.
  • Collaborate with manufacturing, Quality Assurance, Graphics, Supply Chain, and Marketing 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 aesthetic and consumer business unit products for compliance with applicable Health Canada regulations.
  • Maintain up-to-date information regarding 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/or other regulatory agencies.
Requirements
  • Bachelor's degree in science or a related field.
  • Overall 5 years of thorough regulatory affairs experience, with a minimum of 2 years of Canadian Regulatory Affairs experience in pharmaceuticals and/or medical devices and cosmetics.
  • 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 Labeling for OTC and NHP is an asset.
  • Proficiency with Microsoft Word and other common software tools.
  • Experience with electronic review systems.
  • Ability to handle confidential information and materials in an appropriate manner.
  • Excellent communication, interpersonal, and organizational/time management skills.
  • High level of integrity while working under pressure.
  • Ability to function effectively with minimum supervision.
  • Ability to multitask and prioritize.

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