Regulatory Affairs Project Leader

Laval - Quebec - Canada - Life Sciences & Health Care - Pharmaceutical - Regulatory - Academic Bachelor

We’re hiring a Regulatory Affairs Project Leader for our client, a global pharmaceutical company, to join their team. This is a one-year contract opportunity that renews annually.

Feel free to contact

Maria Camanag, Account manager

Apply now

About this role

Responsibilities

  • File regulatory submissions) to Health Canada to maintain compliance for marketed products with a focus on product monographs and drug labels;
  • Update required internal systems and databases with regulatory affairs information, as per company SOPs;
  • Communicate and work with company’s local (e.g., Canada brand team) and global stakeholders, according to SOPs;
  • Prepare ASMF (Active Substance Master File) regulatory submissions to Health Canada;
  • Interact directly with Health Canada, and to address questions on filed submissions to ensure approval;
  • Review promotional and non-promotional material to ensure compliance for all products (marketed or development) from the company portfolios.

About you

Requirements

  • Bachelor’s Degree in Pharmacy or any health-related field;
  • 3+ years’ experience in preparation of regulatory submissions;
  • French and English (written and spoken);
  • Good understanding of the current Health Canada regulations and guidelines, especially clinical and labeling issues;
  • Good teamwork and ability to work independently;
  • Computer knowledge of Microsoft Office Suite; Adobe Acrobat;
  • Organized, attention to detail and deadline driven.

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Publication: PUB283234
  • Location: Laval
  • Market: Life Sciences & Health Care
  • Hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of expertise: Regulatory
  • Closing date: Monday, November 30, 2020
Apply now

Feel free to contact

MC

Maria Camanag

Account manager Brunel Canada - Toronto

+1 416 244 2402

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