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 the new submission of Apotex and Co-partner’s products in US and Canada markets.
Preparation of submission and approval notifications for applications submitted to Regulatory agencies (US and Canada)
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 regulatory markets (US and Canada) to ensure timely approval.
Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets (US and Canada).
Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.
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 response, de
📌 Assistant Manager (Mumbai)
🏢 Apotex
📍 Mumbai