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Associate / Lead Consultant - Regulatory

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

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The Associate or Lead 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 facility licence submissions 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. This role primarily focuses on Health Canada Facility Licencing i.e., Drug Establishment Licence, NHP Site Licence and Medical Device Establishment Licences. The role specifically prioritizes, plans and organizes facility related regulatory projects to ensure smooth implementations. The role may involve coordinating the work of several consultants and includes:

  • Preparation of CoPP submissions
  • Review of drug and NHP labels, claims, and ingredients against Health Canada approved standards
  • Preparation of Drug Establishment License (DEL) applications for new client DELs, amendments, notifications and annual DEL renewals
  • Includes preparation of Site License (SL) applications. amendments and renewals. And submissions through NHPD submission portal
  • Assisting clients in preparation of Quality Assurance Reports (QAR)
  • Responding to clarifications (Clarifax/IRN) from Health Canada within specified time frames
  • Reporting to the Manager of Regulatory Services, the Associate or Lead Consultant is responsible for:
  • 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 compared to regulatory requirements
  • Driving the submission of Health Canada facility licence submissions
  • 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.
  • Prepare and ensure all submission documents are submission ready
  • Supporting the importing team clients by completing regulatory change controls for facility licence changes

Requirements

  • A minimum of a Bachelor of Science degree is required, along with 1-3 years of relevant industry experience. FDA and/or EMA experience is a significant asset.

Benefits

Learn about what makes our company unique at www.qualityandcompliance.com. 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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