Manager - Regulatory Affairs

Job Summary

Responsible for leading Regulatory Affairs individuals accountable for management of life cycle changes including change assessments and submissions all the way to approvals of PLCM (Product Life Cycle Management) projects to support regulatory compliance continued supply of Apotex products. Also responsible for Global Regulatory practices to manage regulatory information in various databases and ensure consistent practices and compliance is maintained at Global Apotex sites. This is to be accomplished by planning and managing the activities of the group. Strong linkages need to be established with R&D, Quality, Operations and the Regulatory Market Affiliates/customers (Canada, US, EU, AUS and NZ) and Regulatory partners at Global Apotex sites. Responsible for coaching team members via sharing of technical knowledge/expertise.

Job Responsibilities

• Responsible for planning wor...