Executive, Global Regulatory Affairs

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 the product life-cycle management of Apotex 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

Job Requirements

A Post-graduate / Graduate degree in Chemistry / Pharmacy / Life Sciences.

Candidate should have knowledge about post-approval change submission requirement and compilation of variation packages for US / CAN / EU / AUS-NZ markets.

Candidate should have minimum 3 years of experience in US / CAN / EU / AUS-NZ markets.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Skills Required

Regulatory Affairs, Regulatory Compliance