Your Opportunity

Tracer Hub is seeking a Regulatory Affairs Associate to support regulatory submissions and facility regulatory compliance for radiopharmaceuticals and cold kits. This position offers a unique opportunity to contribute to the commissioning of the new Calgary Radiopharmaceutical Centre and support new radiopharmaceutical manufacturing capabilities. In this position, you will support regulatory activities for facility commissioning, validation, and operational readiness.

You will collaborate with Quality, Manufacturing, clinical teams, and contractors to assess product, process, and facility changes, evaluate scientific and quality data, and support inspection readiness. Success in this role requires strong scientific judgment, technical writing skills, attention to detail, and the ability to effectively communicate complex technical information to diverse stakeholders.

Key Responsibilities include: Preparing, revising, and reviewing submissions to Health Canada, including New Drug Submissions, Post-Notice of Compliance changes, Drug Master File updates, annual reports, and responses to regulatory requests

- Collaborating effectively with internal and external stakeholders to coordinate document preparation, data collection and resolution of scientific and/or technical issues to support timely regulatory activities
- Supporting facility-related validation, qualification, vendor oversight, and risk management activities in collaboration with project managers, Quality, Operations, and other stakeholders
- Supporting facility licensing, registrations, permits, and regulatory renewals by maintaining facility-related information and documentation
- Reviewing validation and qualification documentation for facility, equipment, processes, suppliers, contractors and service providers to ensure compliance with regulatory requirements, GMP principles, and internal procedures.

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.

Classification: Research I Union: HSAA Facility PROF/TECH Unit and Program: Radiopharmaceutical Centre, Diagnostic Imaging Primary Location: Foothills Medical Centre Location Details: As Per Location Multi-Site: Not Applicable FTE: 1.00 Posting End Date: 25-AUG-2026 Employee Class: Regular Full Time Date Available: 12-OCT-2026 Hours per Shift: 7.75 Length of Shift in weeks: 4 Shifts per cycle: 20 Shift Pattern: Days Days Off: As Per Rotation Minimum Salary: $38.80 Maximum Salary: $51.16 Vehicle Requirement: Not Applicable

Required Qualifications

Diploma or degree in a health or science related field. Registration with applicable professional association or college where required.

Additional Required Qualifications

A combination of education and experience equivalent to 3 - 5 years in regulatory, quality assurance, quality control, or a related technical/scientific field. A basic knowledge of chemistry (such as knowledge of pH values, dilutions, acids, and bases) and analytical testing methods (such as TLC and HPLC). Robust technical writing, editing, and document management skills are required.

Preferred Qualifications

A combination of education and experience equivalent to 5+ years in regulatory affairs, quality assurance, quality control, or a related technical/scientific field. Advanced knowledge of radiopharmaceutical manufacturing, chemistry and microbiology, including analytical testing methods (HPLC, TLC, and sterility testing) is preferred.

📌 Research I (Calgary)
🏢 Alberta Health Services
📍 Calgary