20 Sep
|
The University of British Columbia
|
Vancouver
20 Sep
The University of British Columbia
Vancouver
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 energetic GMP workplace. 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.
📌 Regulatory Affairs Coordinator At Ubc Vancouver
🏢 The University of British Columbia
📍 Vancouver