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, 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 current product registration activities in international markets that include compilation, review & submission of new product registration dossiers, deficiency responses and pre-launch variations etc. Perform due diligence and help cross-functional teams in planning, prioritizing & tracking of planned dossier dispatches/submission and launches respectively.



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. Establish strong linkages with R&D;, Quality, Operations and the Regulatory Market Affiliates/Customers (LATAM, APAC, Caribbean, EMEA, GCC, EU and AUS-NZ market) and Regulatory partners at Global Apotex sites. Implement department-driven projects & support to set up new processes (as applicable) within team and ensure smooth transition & functioning. Responsible for coaching team members via sharing of technical knowledge/expertise.

Job Responsibilities

Schedule and assign projects to Regulatory Affairs team to ensure business timelines are met.
Review, compile and dispatch new product submissions and pre-launch variations.
Handling of deficiencies receiv

📌 Manager - New Product Development International (Mumbai)
🏢 Apotex
📍 Mumbai