Designation - Regulatory Affairs Manager

Location - Mississauga, Ontario

Department - Regulatory Affairs & Quality

Position Summary

Novumgen is seeking an experienced Regulatory Affairs and Quality Manager to lead Canadian regulatory and quality activities for its pharmaceutical and cannabis operations. The role will coordinate Health Canada submissions and licensing, maintain compliant quality systems, support DEL and cannabis activities, prepare the organization for inspections, and work closely with Canadian operations, global teams, manufacturers, laboratories, logistics providers, consultants and commercial partners.

Key Responsibilities

Pharmaceutical Regulatory Affairs

- Develop and manage Canadian regulatory strategies and submission plans for pharmaceutical products.
- Prepare, review and coordinate NDS, ANDS, supplements, amendments, notifications, deficiency responses, DIN-related activities and post-approval changes.
- Coordinate CTD Modules 1 and 2 and review consistency with technical Modules 3, 4 and 5.
- Manage product monographs, bilingual labels, package components, product names and regulatory correspondence with Health Canada.
- Maintain submission trackers, approvals, licences, commitments, product timelines and regulatory records.

Pharmaceutical Quality and DEL Compliance

- Establish and maintain the Canadian pharmaceutical quality management system, including SOPs, forms, specifications, protocols, reports and quality agreements.
- Support Drug Establishment Licence applications, amendments, renewals, foreign building evidence, importation, packaging, labelling, testing, storage and distribution activities.
- Manage deviations, investigations, CAPAs, change controls, complaints, recalls, returns, risk assessments and product quality issues.
- Qualify and monitor manufacturers,



API suppliers, laboratories, warehouses, distributors, third-party logistics providers and other vendors.
- Support batch-document review, release requirements, temperature controls, audits, mock recalls and Health Canada inspection readiness.

Cannabis Regulatory and Quality

- Support cannabis processing and related licence applications, amendments, renewals and ongoing Health Canada compliance.
- Maintain the cannabis quality system covering processing, packaging, labelling, testing, storage, quarantine, release, inventory, destruction, returns and recordkeeping.
- Review production, packaging, testing and release documentation and coordinate with the Responsible Person, Head of Security, operations and approved laboratories.
- Manage cannabis deviations, CAPAs, complaints, change controls, sanitation, pest control, preventive maintenance, recalls and inspection responses.
- Support CRA cannabis excise licensing, stamps and inventory reconciliation where applicable.

Qualifications and Experience

- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences or a related discipline.
- Typically 5 or more years of relevant experience in Regulatory Affairs, Quality Assurance or a combined RA/QA role.
- Robust knowledge of Health Canada pharmaceutical requirements, GMP/GDP, CTD submissions and Canadian quality systems.
- Experience with NDS/ANDS activities, DEL compliance, audits, inspections, SOPs, deviations, CAPAs, complaints and vendor qualification.
- Cannabis processing, packaging, QAP, licensing or quality experience is strongly preferred.
- Strong technical writing, organization, communication, judgment and problem-solving skills.
- Ability to work independently in a developing Canadian operation and coordinate effectively with international teams.

📌 Regulatory Affairs Manager (Canada)
🏢 NOVUMGEN
📍 Canada