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Regulatory Affairs Expert

1 month ago

Mississauga, Ontario, Canada Q&C Full time
Job Title: Lead Regulatory Affairs Consultant

We are seeking a highly skilled and experienced Lead Regulatory Affairs Consultant to join our team at Q&C. As a key member of our Regulatory Services department, you will play a critical role in maximizing and protecting the commercial interests of our clients.

Key Responsibilities:

  • Drive the registration of various products according to applicable regulations
  • Prioritize, plan, and organize regulatory-related projects to ensure smooth implementations
  • Coordinate the work of several consultants as needed
  • Prepare and submit regulatory documents, including NHP PLAs, DIN-A Labelling Standard, and Level III PDC submissions
  • Review clinical and non-clinical studies and assess the possibility of claims/claims substantiation
  • Perform Promotional Material Review and have working knowledge of PAAB guidelines
  • Assist with Product Lifecycle Management for Division 1 and 8 drugs
  • Evaluate Regulatory product classification and develop pathways

Requirements:

  • A minimum of a Bachelor of Science degree
  • 5-8 years of relevant industry experience
  • RAC Designation preferred

What We Offer:

  • A dynamic and supportive work environment
  • The opportunity to work with a talented team of professionals
  • A competitive compensation package

Accommodations:

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.