Regulatory Affairs Coordinator – Advanced Therapeutics Manufacturing

About the role

The Advanced Therapeutics Manufacturing Facility (ATMF) at UBC seeks a Regulatory Affairs Coordinator to manage regulatory activities for GMP‑based advanced therapeutic production. Reporting to the Director of GMP Operations, the incumbent will interpret guidelines, coordinate submissions, and ensure compliance across Canadian, U.S., and European health authorities.

Key responsibilities

• Plan and execute regulatory strategies for ATMF programs, interpreting Health Canada, FDA, EMA, and ICH guidance.
• Lead preparation, review, and submission of pre‑CTA, CTA, IND, NDS, and amendment packages, ensuring completeness and regulatory sufficiency.
• Provide cross‑functional regulatory support, represent ATMF in authority interactions, and support inspection‑readiness activities.

Required profile

• Ability to independently manage assigned regulatory activities and assess regulatory risks.
• Strong judgment and technical expertise in a fast‑paced GMP environment.
• Effective collaboration with Quality Assurance, Manufacturing, Process Development, and external partners.

Required skills

• Knowledge of Health Canada, FDA, EMA, and ICH regulatory guidelines.
• Experience with Chemistry, Manufacturing, and Controls (CMC) documentation.
• Proficiency using eCTD electronic submission tools and regulatory information management systems.