Regulatory Affairs Lead

5 days ago

Mississauga, Ontario, Canada Q&C Full time
About the Role

The Lead/Senior Consultant--Regulatory role at Q&C 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 regulatory authorities, product licensing, and compliance activities.

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.

Key Responsibilities
  • Drive product submissions to regulatory authorities
  • Prepare and submit product license 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 should have working knowledge of regulatory 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 regulated products
  • Assess and manage post-market product changes along with product lifecycle
  • Open to learning and working in new area like Environmental Compliance (regulatory requirements)
  • Respond to clarifications from regulatory authorities within the specified time frame
Preferred Qualifications
  • Compile and manage regulatory documents, such as Drug Establishment License, Medical Device Establishment Licence and Site License
  • Pharmacovigilance experience
  • Regulatory experience with 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 (regulatory requirements)
About Q&C

Q&C is a company that welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

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

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