Regulatory Affairs & Quality Assurance Specialist
About the Role
We are seeking a Regulatory Affairs & Quality Assurance Specialist to support Health Canada regulatory activities and quality compliance within our pharmaceutical distribution operations.
The successful candidate will work on regulatory submissions, licensing, controlled substances compliance, quality systems, and client regulatory projects.
Key Responsibilities
- Prepare and maintain Health Canada regulatory submissions, licences, amendments, and renewals.
- Support DEL, NPN/NHP, MDEL, and other applicable regulatory activities.
- Coordinate regulatory documentation for products, manufacturers, foreign sites, laboratories, and clients.
- Review product labels, packaging, GMP documentation, and other regulatory records for Canadian compliance.
- Respond to Health Canada requests and maintain regulatory records, trackers, and deadlines.
- Ensure compliance with GMP, GDP, SOPs, and Health Canada requirements.
- Support deviations, CAPAs, change controls, complaints, recalls, temperature excursions, and investigations.
- Participate in internal, client, and regulatory audits.
- Ensure compliance with the Controlled Drugs and Substances Act (CDSA), Narcotic Control Regulations (NCR), and applicable Health Canada requirements.
- Maintain controlled substance records for receipt, storage, distribution, inventory reconciliation, destruction, loss/theft, and record retention.
- Perform controlled substance inventory reconciliations and support licensing, renewals, amendments, and required regulatory reporting.
- Work closely with Operations, Warehouse, QA, clients, and external partners on regulatory and compliance matters.
Preferred Qualifications
- Experience in Regulatory Affairs within the pharmaceutical, NHP, medical device, or healthcare industry.
- Knowledge of Health Canada, DEL, NHP/NPN, MDEL, GMP, GDP, and controlled substances requirements.
- Experience with regulatory submissions, licensing, CAPAs, deviations, and audits is an asset.
- Strong documentation, technical writing, organizational, and communication skills.
Benefits
- Dental care
- Life insurance
- Paid time off
Job Type: Full-time
Work Location: Mississauga, ON
Pay: $40,000.00-$50,000.00 per year
Benefits:
- Dental care
- Life insurance
- Paid time off
Work Location: In person
