Bilingual Team Lead, Regulatory Affairs

PUB353577

People in a lab talking

About this job

  • Market: Life Sciences & Health Care
  • Branche: Pharmaceutical
  • Area of expertise: Regulatory
  • Location: Ontario

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor
  • Closing date: Saturday, August 13, 2022

About this role: Bilingual Team Lead, Regulatory Affairs

Introduction

We are currently hiring a Bilingual Team Lead Regulatory Affairs for our client, a global pharmaceutical company committed to healthcare solutions from prevention to treatment. Our client has state-of-the-art facilities for producing medicines and vaccines in variety of therapeutic areas including Diabetes & Cardiovascular, Oncology, Cardiology, Rare Diseases, and Multiple Sclerosis.

The Team Lead Regulatory Affairs will communicate with the Regulatory Affairs Head and other Regulatory Affairs team members to ensure efficient ways of working and coordination of the regulatory affairs. This is a long-term contract role with possibility for renewal and a great opportunity to work remotely.

Responsibilities

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

What you need to bring:

Requirements

  • Bachelor’s Degree in Pharmacy or any health-related field
  • 3-5 years’ experience in preparation of regulatory submissions
  • Fluency in French and English (written and spoken)
  • Good understanding of the current Health Canada regulations and guidelines
  • Strong leadership, and decision-making skills Excellent communication skills
  • Organized, attention to detail, and deadline driven

Benefits:

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.

Anything Else?

Anything Else?

About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 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.

  • Job references (optional)
  • Motivation Letter (optional)
  • Resume
Apply now

Any questions remaining?

Your consultant, Michael Leung is happy to clarify anything about this vacancy. When reaching out, use this number:
PUB353577

Account manager

Michael Leung
Brunel Canada - Toronto
m.leung@brunel.net