Job Title

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 Bachelors degree in Pharmacy or a health-related discipline 710 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. Well 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. Thats what we continually strive for. Over 45 years, weve created a global network of interesting clients and talented individuals working together through a vast array of services.