About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, creative 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
Leads a team responsible for new product registrations and lifecycle management across global markets, including LATAM, APAC, Caribbean, EMEA, GCC, EU, and ANZ. Oversees dossier compilation, review, submissions, deficiency responses, and pre-launch regulatory activities to support successful product approvals and launches. Partners closely with R&D;, Quality, Operations, and regional affiliates to prioritize and track regulatory deliverables,
ensure compliance with global regulatory requirements, and maintain data integrity across regulatory systems. Additionally, drives process improvement initiatives, supports implementation of new regulatory practices, and develops team capability through technical guidance, coaching, and performance leadership.
Key Responsibilities / Profile Highlights
• Extensive hands-on expertise in CMC regulatory affairs supporting new product registrations across global markets, including European Union (EU), GCC, LATAM, APAC (including Australia & New Zealand), and Caribbean regions.
• Lead dossier compilation, review, and submission activities for new product registrations, ensuring compliance with country-specific and international regulatory requirements.
• Manage and coordinate responses to health authority deficiencies, queries, and information requests, driving successful product approvals and timely market launches.
• Prov
📌 Regulatory Affairs Manager (Mumbai)
🏢 Apotex
📍 Mumbai