Regulatory Affairs Manager

Regulatory Affairs Manager (Contract – Renewable)

Remote – Ontario

Role Overview

We are seeking an experienced Regulatory Affairs Manager to support clinical-stage and lifecycle regulatory activities for innovative pharmaceutical products. This role will play a key leadership position in ensuring regulatory compliance, execution, and alignment across clinical development and post-approval activities in Canada.

The Regulatory Affairs Manager will act as a senior regulatory contributor and point of coordination, working closely with internal regulatory leadership, cross-functional partners, and Health Canada. This role requires a strong background in clinical regulatory submissions, the ability to operate hands-on, and experience guiding regulatory work in a collaborative, matrixed environment.

Key Responsibilities

• Lead and execute Canadian regulatory activities across clinical development and marketed products, ensuring compliance with Health Canada requirements
• Prepare, review, and submit clinical and lifecycle regulatory filings, including variations, labeling updates, and post-approval submissions for innovative drugs
• Serve as a primary regulatory contact for Health Canada interactions, managing questions, clarifications, and follow-up during review cycles
• Provide regulatory guidance and oversight to supporting regulatory resources to ensure high-quality, timely deliverables
• Collaborate with cross-functional stakeholders including Clinical, Medical, Quality, CMC, and Global Regulatory teams to align regulatory strategy and execution
• Review promotional and non-promotional materials to ensure regulatory compliance and consistency with approved labeling
• Maintain accurate regulatory documentation and records within internal systems in accordance with SOPs and regulatory standards
• Support continuous improvement of regulatory processes and ways of working

Required Qualifications

• Bachelor’s degree in Pharmacy or a health-related discipline
• 7–10 years of experience in Regulatory Affairs with a strong focus on clinical regulatory submissions for innovative pharmaceutical products
• Demonstrated experience working with Health Canada regulations and guidelines across clinical and lifecycle stages
• Prior experience providing leadership, guidance, or oversight to regulatory team members or project resources
• Strong understanding of eCTD publishing requirements and regulatory documentation standards
• Excellent communication, judgment, and decision-making skills
• Ability to manage multiple priorities in a fast-paced, regulated environment
• Proficiency with Microsoft Office and Adobe Acrobat
• Bilingual French and English (written and spoken) considered an asset

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.