Regulatory Affairs Team Lead in Laval: Profession with future

Canada, Laval

Fulltime: 40 hrs a week

Experience: 2 years

Closing: September 27, 2024

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Introduction

Regulatory Affairs Team Lead (renewable contract)

Remote - Ontario or Quebec

What are you going to do

Responsibilities

Communicate with the company's Regulatory Affairs (RA) Head and other RA staff to ensure 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 (from the company's portfolios) to Health Canada to maintain compliance for marketed products with a focus on product monographs and drug labels
Update required to the company's internal systems and databases with regulatory affairs information, as per the company's SOP's
Communicate and work with the company's local (eg, Canada brand team) and global stakeholders, according to the company's SOPs
Prepare SNDS, PRCI and YBPR 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 the company's portfolios

Essential skills and knowledge

Requirements

Bachelor's degree in pharmacy or any health-related field
Previous managerial experience
Minimum of 3-5 years previous experience in the preparation of regulatory submissions specific to innovative drugs
French and English (written and spoken) an asset.
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

What we offer

What We Offer

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

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.