Lead Regulatory Affairs Consultant

The Lead / Senior Consultant Regulatory role focuses on maximizing and protecting the commercial interests of our clients.

Our consultants often work closely with marketing, quality assurance, project management and legal teams, so that drug development, filing of submissions and maintenance of product compliance activities are undertaken in a timely manner.

We are looking for consultants who want to apply their in-depth regulatory knowledge and out-of-the-box thinking to challenging projects with our clients.

Our projects cover submissions to TPD, NNHPD, BRDD and MDB.

In this broad-based role, you will drive the registration of various products according to applicable regulations. The role specifically prioritizes, plans and organizes regulatory-related projects to ensure smooth implementations.

The role may involve coordinating the work of several consultants.

Knowledge and experience in the following are required :

• Driving product submissions to Health Canada is required
• 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 should 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 area like Environmental Compliance (CEPA and relevant Regulations)
• Respond to clarifications from Health Canada within the specified time frame

Knowledge and experience in the following is preferred :

• 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. 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 preferred.

Benefits

If you're a Regulatory professional in the Pharmaceutical industry, we have the environment and exposure to the type of work you want to do.

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.