Regulatory Affairs Manager
The role is responsible for managing regulatory product registration filings and dossier compilation for key markets including Canada, UK/EU, and AU. It involves interacting with regulatory agencies, specifically Health Canada, and coordinating with global regulatory teams to ensure operational excellence.
- On-site
- Concord, ON
- Posted Aug 4, 2026
- Apply by Sep 3, 2026
- 1 position
Job summary
Job Description Purpose: This position will be responsible for regulatory product registration fillings in key markets including Canada, UK/EU and AU and will need to support US filings as required. The role will involve compilation of dossiers for filing in key markets, responding to queries from the regulatory agencies, and interacting with stakeholders. This position will also be responsible for managing regulatory communications with Health Canada. Position / Job Title: Manager Department: Regulatory Affairs Reporting To: AGM/GM – Regulatory Affairs (Key Markets) Location: Ontario Years of Experience: 10-12 years Job Responsibilities / Deliverables: • Compilation of dossiers for filings in key markets including Canada, UK/EU and AU for generic and new products. • Responding to queries from regulatory agencies. • Co-ordinate with stakeholders and cross-functional team for filing documents and data. • Manage product registration filings in key markets. • Manage communications with Health Canada. • Manage meetings and discussions with Health Canada. • Support as needed, US filings in the pre-approval or post approval space. • Coordinate with global regulatory teams. • Ensure business growth and operational excellence within regulatory set up. Qualifications & Pre-Requisites: • B.S/M.S in Pharmaceutical Sciences • Proficiency in Regulatory Affairs. • Knowledge about Pharmaceutical Product Development. • Excellent communication, planning, analytical and interpersonal skills. • Prior work experience with Health Canada is preferred.
What you’ll do
The role is responsible for managing regulatory product registration filings and dossier compilation for key markets including Canada, UK/EU, and AU. It involves interacting with regulatory agencies, specifically Health Canada, and coordinating with global regulatory teams to ensure operational excellence.
Requirements
Candidates must have a B.S. or M.S. in Pharmaceutical Sciences and 10-12 years of experience in regulatory affairs. Proficiency in pharmaceutical product development and prior experience working with Health Canada is preferred.
Other relevant skills
Identified from the job description. Confirm important requirements above.
- Regulatory Affairs
- Product Registration
- Dossier Compilation
- Health Canada Communications
- Pharmaceutical Product Development
- Stakeholder Management
- Cross-functional Coordination
- Analytical Skills
- Interpersonal Skills
- Planning
Job areas
- Healthcare
- Science & Research
- Manufacturing
- Management & Leadership
- Legal
Additional details
- Minimum education
- Bachelor’s degree
- Minimum experience
- 10+ years
- Apply by
- Sep 3, 2026
- Posting language
- English
- Working hours
- 40 hours per week
- Seniority
- Mid-Senior level
- Application method
- Direct apply is available