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
- Compilation and submission of current registration applications, deficiency responses and pre-launch variations for assigned products in international markets.
- Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures.
- Handling of change control review (CCR) related activities like confirmation on change assessment, document verification and closing of RA approval tracker.
- Supporting and/or coordinating regulatory affairs projects, as assigned.
- Preparation of submission and approval notifications for new product applications submitted to Regulatory agencies.
- Should review applications to ensure one cycle approval.
- Support leaders are developing robust processes and systems to build high quality applications and reduce deficiencies from health agencies.
- Support Global Project Management team on activities related to project planning and execution.
Job Responsibilities
- Support in review and compilation of applications (i.e., new registration applications, deficiency responses and pre-launch variations) of drug products to international market.
- Support in review and compilation of deficiency packages for assigned products within given timeline & with high quality measured against compiler checklist maintained by team.
- Review and compilation of New Product applications for internat
📌 Lead Executive (Mumbai)
🏢 Apotex
📍 Mumbai
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