About Apotex Inc.Apotex is a Canadian‑based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, cutting-edge branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian‑based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.Job SummaryThe incumbent provides strategic leadership and oversight of a regulatory affairs team responsible for the preparation and submission of applications for the assigned product portfolio across all dosage forms,



for products developed and/or manufactured internally or through external partners, supporting the United States and Canadian markets. This role drives regulatory strategy, ensuring timely and compliant preparation, submission, and approval of dossiers to the FDA and Health Canada, while navigating complex regulatory frameworks and evolving guidance. The Director partners externally with development partners and internally, cross‑functionally with R&D, clinical, quality, manufacturing and commercial teams to align regulatory objectives with business goals, proactively identify and mitigate regulatory risks, and support successful product submissions, approvals and launches, and subsequent

📌 Director, New Product Development (Regulatory Affairs) (Toronto)
🏢 Apotex
📍 Toronto