About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, cutting-edge medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative 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.

For more information visit: www.apotex.com.

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 (Caribbean, EMEA, GCC, LATAM, APAC and any other international markets as assigned) and Regulatory partners at Global Apotex sites. Responsible for coaching team members via sharing of technical knowledge/expertise.

Job Responsibilities
- Responsible for planning workload / projects (i.e. change assessments, submissions, training plans, deficiency responses, audits etc.) for international / rest of world markets and managing processes to ensure objectives of department and submission and approval timelines are met. Prioritizes projects in support of commercial business needs.
- Reviews and ensures timely submission of post-launch variations and completes any other activities as assigned,

📌 Senior Manager (Mumbai)
🏢 Apotex
📍 Mumbai