Regulatory Affairs Coordinator at UBC
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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
- 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
- Strong writing and project management skills
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Regulatory Affairs Coordinator at UBC
4 days ago
Vancouver, Metro Vancouver Regional District, Canada The University of British Columbia Full-time $90,000 - $120,000 ContractDrive 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...
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