Regulatory Affairs Team Leader

PUB283236

About this role

We’re hiring a Regulatory Affairs Team Lead for a pharmaceutical company for a long term contract (renewable) in Laval, QC

  • Communicate with staff in efficient ways of working and coordination of regulatory affairs work in scope;
  • Provide managerial support to team and direct and supervise daily work;
  • 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 SOP’s;
  • Communicate and work with Sanofi local (eg, 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 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 portfolios.

Requirements

  • Bachelor degree in pharmacy or any health-related field;
  • Previous managerial experience;
  • Minimum of 3-5 years previous experience in the preparation of regulatory submissions;
  • French and English (written and spoken) ;
  • Strong leadership, and decision-making skills;
  • Excellent communication skills;
  • Ability to build effective teams;
  • Excellent understanding of the current Health Canada regulations and guidelines, including publishing eCTD requirements;
  • Computer knowledge of Microsoft Office Suite; Adobe Acrobat.

Benefits

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.

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Join the Brunel Family

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.

Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume or up-to-date LinkedIn / Xing profile
Apply now

Any questions remaining?

Your consultant, Diana Grodowski is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB283236

Account manager

Diana Grodowski
Brunel Canada - Toronto
d.grodowski@brunel.net

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