Regulatory Affairs Specialist

4 weeks ago

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

The Lead Regulatory Affairs Consultant plays a crucial role in maximizing and protecting the commercial interests of our clients. This position requires close collaboration with various teams, including marketing, quality assurance, project management, and legal, to ensure timely completion of drug development, submissions, and product compliance activities.

We are seeking a highly skilled consultant with in-depth regulatory knowledge and the ability to think creatively. Our projects cover a range of submissions, including TPD, NNHPD, BRDD, and MDB. The ideal candidate will drive the registration of various products according to applicable regulations, prioritize, plan, and organize regulatory-related projects for smooth implementation, and may coordinate the work of several consultants.

Key Responsibilities:

  • Drive product submissions to Health Canada
  • Prepare and submit NHP PLAs - Class I, II applications
  • NHP Class III PLAs - Research and Author Safety and Efficacy summaries
  • Prepare and submit NHP PLAs for Amendments, Notifications, and Product Licence transfers
  • 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
  • Prepare and submit Cosmetic Notifications and Amendments
  • Perform Label reviews for Drugs, NHPs, Cosmetics
  • Evaluate Regulatory product classification and develop pathways
  • Prepare and submit DIN-A Labelling Standard, DIN-F Category IV Monograph, DIN-D Labelling Standard, Level III PDC submissions (PDCs)
  • Assist with Product Lifecycle Management for Division 1 and 8 drugs
  • Assess and manage post-market product changes along with product lifecycle
  • Open to learning and working in new areas like Environmental Compliance (CEPA and relevant Regulations)
  • Respond to clarifications from Health Canada within the specified time frame

Preferred Qualifications:

  • Compile and manage Drug Establishment License, Medical Device Establishment Licence, and Site License
  • Pharmacovigilance experience
  • Health Canada Class II, III, and IV Medical Device Applications
  • Structured Product Labelling (SPL) working experience
  • Working knowledge of Environment Compliance like implementation of Environment Management Plan (ECCC)

You will be reporting to the Manager, Regulatory Services. To be successful in this role, you will need to maintain up-to-date knowledge of regional and national regulations, guidelines, and advisory documents, as well as advances in relevant scientific fields.

Requirements:

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

Benefits:

Q&C welcomes and encourages 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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