Regulatory Affairs Manager
Canada, Ontario
Fulltime: 40 hrs a week / CA$ 90000 - 125000 per year
Experience: 6-9 Years
Pharmaceuticals
Introduction
Regulatory Affairs Manager (Contract - Renewable)
Remote - Ontario
What are you going to do
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
Essential skills and knowledgeÂ
Requirements
- 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
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.