Regulatory Affairs Co-Op – Toronto, ON

The Regulatory Affairs department is responsible for the registration of new pharmaceutical products, new product indications and line extensions and for compliance with Health Canada regulatory requirements for drug products.

Responsibilities:

• Assist in the preparation and compilation of regulatory submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and other submissions to support the lifecycle management of pharmaceutical products.
• Assist in the development of responses to Health Canada queries in relation to clinical efficacy and safety, clinical pharmacology, biopharmaceutics and preclinical subject matter (e.g., Clarification letters, Notice of Non-Compliance (NON), and Notice of Deficiency (NOD)) in a timely manner.
• Collaborate with internal partners to ensure delivery of regulatory affairs activities to meet strategic business objectives and goa...