Research I - Regulatory Affairs Associate

Your Opportunity:

Tracer HUB is seeking a Regulatory Affairs Associate to support the preparation, review, and coordination of regulatory submissions to Health Canada for radiopharmaceutical and cold kits. The role is ideal for someone who excels at scientific writing, has strong organizational skills, and enjoys working collaboratively with multiple teams. You will play a key role in ensuring our radiopharmaceuticals are safe, high-quality, and compliant with Health Canada regulations. About This Role: In this position, you will prepare and maintain regulatory submissions for marketed and investigational radiopharmaceutical products manufactured in Edmonton and Calgary. You will work closely with diverse stakeholders to gather, interpret, and compile scientific and quality data. Success requires strong attention to detail, critical thinking, and the ability to transform technical information into clear regulatory documents. Key Responsibilities: Prepare, revise, and review Health Canada submissions, including New Drug Submissions, Post-Notice of Compliance changes, drug master file updates, annual reports, and responses to information requests. Develop and refine key documents such as Product Monographs and Quality Overview Summaries. Evaluate scientific and quality data from internal teams and compile them into cohesive compliant submission packages. Conduct regulatory assessments for product lifecycle changes, including manufacturing and analytical method updates. Support Quality Assurance through preparation and review of validation documents, annual summary reports, and product specification files. Maintain current knowledge of Health Canada, ICH, USP, and PIC/S guidelines and contribute to continuous improvement of regulatory and quality standards.

Description:

As a Research I, you will be working with research teams which are generating and disseminating new knowledge that assists with advancing the understanding of health disciplines and various health and medical concerns. Working under the guidance of the principal investigator, you will be responsible for preparing and submitting research documents, collecting and reviewing a variety of information related to the study, and monitoring study compliance. You will also assist with the recruitment of study participants and initiate consenting of study and/or trial participants and may complete lab work to support research activities.