Introductie

Regulatory Affairs Manager (Contract - Renewable)

Remote - Ontario

Functieomschrijving

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

Vereisten

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

Arbeidsvoorwaarden

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.

Sluitingsdatum: 24 mei 2026

Solliciteren

Contactgegevens vacature

Vacaturenummer: CR-279621

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Corporate recruiter

Alyssa DeRosario

+1 403 539 5009

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