Regulatory Affairs Leader

About the role

Apotex Inc. is seeking a Regulatory Affairs Leader to oversee the submission, approval, and maintenance of sanitary certificates and health licences for its pharmaceutical portfolio. The role ensures compliance with local health regulations, supports product commercialization, and coordinates pharmacovigilance activities.

Key responsibilities

• Prepare, endorse, and submit health licence applications and registrations for all Apotex products.
• Monitor product destruction, coordinate documentation with accounting and warehouse teams, and ensure compliance with authority requirements.
• Process regulatory documentation, submit applications to the National Directorate of Pharmacy and Drugs, and track registrations, certifications, and updates.
• Coordinate shipment of documentation and samples, purchase and import standards required for sanitary registration.
• Verify product quality against Ministry of Health standards and release products for commercialization.
• Manage authentications, legalizations, translations, and certifications needed for market entry.
• Support participation in public bidding processes.
• Maintain a pharmacovigilance system, monitor adverse drug reactions, and ensure compliance with Ministry of Health reporting requirements.

Required profile

• Proven experience managing sanitary certificate submissions and health licence registrations.
• Familiarity with national health authority processes and pharmaceutical regulations.
• Ability to coordinate cross‑functional teams including regulatory, accounting, and warehouse departments.
• Experience handling product destruction documentation and public bidding procedures.
• Knowledge of pharmacovigilance systems and adverse event reporting.

Required skills

What we offer

• Opportunity to lead regulatory affairs for a global pharmaceutical company.
• Collaborative environment with regional and global teams.
• Exposure to a broad portfolio of generic, biosimilar, and innovative products.