Regulatory Affairs Specialist

4 weeks ago


Mississauga, Ontario, Canada Q&C Full time

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Q&C. In this role, you will be responsible for maximizing and protecting the commercial interests of our clients by driving product submissions to Health Canada and ensuring compliance with applicable regulations.

Key Responsibilities

  • Prepare and submit NHP PLAs - Class I, II applications
  • Review clinical and non-clinical studies and assess possibility of claims/claims substantiation
  • Perform Promotional Material Review (All categories - OTC, Prescription, NHPs, Devices), and have working knowledge of PAAB guidelines
  • Assist with Product Lifecycle Management for Division 1 and 8 drugs
  • Assess and manage post-market product changes along with product lifecycle

Requirements

A minimum of a Bachelor of Science degree is required, along with 5-8 years of relevant industry experience. RAC Designation preferred.

About Q&C

We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.



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