Regulatory Affairs Expert

2 weeks ago

Mississauga, Ontario, Canada Q&C Full time

The role of Lead Regulatory Affairs Consultant at Q&C focuses on maximizing and protecting the commercial interests of our clients. Our consultants work closely with marketing, quality assurance, project management, and legal teams to ensure timely completion of drug development, submissions, and product compliance activities.

We are seeking consultants with in-depth regulatory knowledge and out-of-the-box thinking to tackle challenging projects with our clients. Our projects involve submissions to various regulatory bodies, including TPD, NNHPD, BRDD, and MDB.

In this role, you will drive the registration of various products according to applicable regulations. You will prioritize, plan, and organize regulatory-related projects to ensure smooth implementations. This may involve coordinating the work of several consultants.

Key responsibilities include:

  • Driving product submissions to Health Canada
  • Preparing and submitting NHP PLAs - Class I, II applications
  • NHP Class III PLAs - Research and Author Safety and Efficacy summaries
  • Preparing and submitting NHP PLAs for Amendments, Notifications, and Product Licence transfers
  • Reviewing clinical and non-clinical studies and assessing the possibility of claims/claims substantiation
  • Performing Promotional Material Review (All categories - OTC, Prescription, NHPs, Devices), and having working knowledge of PAAB guidelines
  • Preparing and submitting Cosmetic Notifications and Amendments
  • Performing Label reviews for Drugs, NHPs, Cosmetics
  • Evaluating Regulatory product classification and developing pathways
  • Preparing and submitting DIN-A Labelling Standard, DIN-F Category IV Monograph, DIN-D Labelling Standard, Level III PDC submissions (PDCs)
  • Assisting with Product Lifecycle Management for Division 1 and 8 drugs
  • Assessing and managing post-market product changes along with product lifecycle
  • Open to learning and working in new areas like Environmental Compliance (CEPA and relevant Regulations)
  • Responding to clarifications from Health Canada within the specified time frame

Preferred qualifications include:

  • Compiling and managing 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. You will also be required to maintain up-to-date knowledge of regional and national regulations, guidelines, and advisory documents, along with 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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