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Senior Consultant - Regulatory

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Location: Mississauga
Company: Q&C
Hours: Full time

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The 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:

  • Prescription OTC, NHP, and medical device submissions
  • Authoring of CTD Modules 1, 2, 3, 4 and 5 reports and risk management plans
  • Negotiating and interacting with health authorities
  • Assessing and managing post-market product changes along with product lifecycle
  • Compile and manage Drug Establishment License, Medical Device Establishment Licence and Site License
  • Respond to clarifications from Health Canada within the specified time frame
  • Establishing project plans that capture all aspects of the scope of work
  • Prioritizing and managing regulatory team projects
  • Completing critical assessments of data and documents to identify gaps against regulatory requirements
  • Driving product submissions to Health Canada is required, FDA and EMA product submissions will be an asset.
  • Strategize and Negotiate product submissions, data requirements with Health Canada
  • Liaise with Health Canada to obtain product and site licensing clarifications
  • Developing and maintaining excellent working relations with Health Canada, Provincial Regulatory Bodies as well as Industry Association taskforces

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. FDA and/or EMA experience is a significant asset. 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.

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