Drive compliance in advanced therapeutics at UBC's ATMF as a Regulatory Affairs Coordinator. Manage regulatory submissions and ensure alignment with Health Canada and FDA standards in a dynamic GMP environment.

Reporting to the Director of GMP Operations, this role involves coordinating regulatory activities crucial for clinical trials and biotechnology advancements. Ideal candidates will showcase expertise in interpreting regulations and preparing submissions per Health Canada, FDA, and EMA guidelines. Collaborating cross-functionally, you will have a pivotal impact on product development processes and CMC documentation.

Key Responsibilities:
• Plan and manage regulatory affairs activities for GMP programs
• Prepare and submit required regulatory documentation




• Evaluate and interpret guidance from health authorities
• Coordinate with functional teams on compliance and submissions
• Monitor regulatory intelligence and updates for communication

Requirements:
• Bachelor's degree in Life Sciences or related field
• Minimum three years of regulatory experience
• Familiarity with ICH and GMP principles
• Expertise in advanced therapy modalities
• Robust writing and project management skills

Enhance regulatory compliance and support groundbreaking therapeutics at UBC's ATMF.
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📌 Regulatory Affairs Coordinator at UBC (British Columbia)
🏢 The University of British Columbia
📍 British Columbia