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, cutting-edge 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

Preparation of new submissions and deficiency responses to Regulatory agencies (US and Canada) for Injectables (Sterile Dosage Forms)
Review of quality documents required for regulatory NPD submissions and deficiency responses.
Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures.
Leading and/or coordinating regulatory affairs projects, as assigned.
Job Responsibilities





Responsible for the preparation and review of quality regulatory NPD submissions for various markets (US and Canada) to ensure timely approval for Injectables (Sterile Dosage Forms).
Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets (US and Canada).
Responsible for review of quality/regulatory documents for new submissions and deficiency responses.
Accountable for assessment, coordination and compilation of deficiency responses in a timely manner.
Works with other functional areas to resolve issues related to information for regulatory submissions.
Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for deficiency resp

📌 Executive - New Product Development (Mumbai)
🏢 Apotex
📍 Mumbai