Support in preparation of new product submissions and responsible for product life-cycle management of Apotex products in US and Canada markets
Preparation of submission and approval notifications for applications submitted to Regulatory agencies
Responsible for the preparation and review of quality regulatory PLCM submissions for various markets to ensure timely approval
Support in preparation of NPD submission for various markets to ensure timely approval
Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance
Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions

A Post-graduate/Graduate degree in Chemistry/Pharmacy/Life Sciences
Knowledge about pre and post-approval change submission requirement and compilation of new dossier/variation packages for US/CAN/EU/AUS-NZ markets
Minimum 1 years of experience in US/CAN/EU/AUS-NZ markets

Senior Analyst, GBS GRA

About this role