Regulatory Affairs Team Lead

3 weeks ago

ontario, Canada Brunel Full time

Regulatory Affairs Team Lead (renewable contract)

Remote – Ontario or Quebec


Introduction

We are hiring a Regulatory Affairs Team Lead for our client to work remotely in Ontario or Quebec. The Regulatory Affairs Team Lead will provide leadership to Managed Services team (Regulatory Affairs Project Leader, Documentation Specialist) and be accountable for timely, quality delivery of services as stated in Statement of Work / Job Descriptions of Managed Service Regulatory Affairs staff. The successful candidate will be responsible for performing the same duties as the Managed Services Regulatory Affairs Project Leader to ensure all compliance regulatory submissions and review of promotional and non-promotional material are completed. This is a 1-year contract position that is renewable.


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


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 clinical 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

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.


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.

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