Assistant Support Manager

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.
Support GBS GRA labelling team for preparation, compilation and review of applications submitted to Health Canada and US FDA
Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures
Monitors and reports on the progress/status of submissions, planned changes to the Reporting Manager
Review assigned applications to ensure all documents involved are of high quality and error free, to facilitate One Cycle review. Documents should be in line with expectations from Regulatory agency and in compliance with regulatory guidelines
Leading and/or coordinating regulatory affairs projects, as assigned.
Responsible to respond to queries received for assigned products from Health Canada/USFDA within given timeline & with high quality
Building applications into eCTD format and ensure documents meet strict internal and regulatory standards
Applications/documents are of high-quality standard to ensure one cycle review from Regulatory authorities
Support reporting manager in developing submission strategies and building technical knowledge within team
Ensure preparation of all required forms and documents for submission projects for Health Canada
Ensure applications are peer reviewed (as per agreed timeline) and comments are addressed as soon as possible to facilitate DocuBridge upload for final publishing
For Artwork management, create the BLUE Project for Non-Commercial and Commercial Workflow
Create and update the RIMS record, CCR-QMS, LAMS-BLUE projects to reflect current status
Handling of Common Electronic Submission Gateway (ESG) for submission of applications for US & Canada market
Accountable to support overall functioning of team and support reporting manager as and when required
Act as a support to reporting manager for planning and execution of trainings to newly joined team members
Timely complete all assigned training in training portal
Provides regulatory support to stakeholders as & when required
Works with internal and external stakeholders to resolve issues related to information for regulatory submissions and change control documentation
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies
A Postgraduate/Graduate in Pharmacy/ Science

Knowledge and/or understanding of regulatory requirements for filing labelling applications to USFDA, Health Canada or ROW markets
Ability to be flexible and multi-task in a rapidly changing environment
Demonstrate good writing skills and compilation of submission documents
Proof-reading ability for reviewing technical documents required for dossier preparation
Attention to detail to check packaging artwork material and specifications Collaborate with team members
Experience
Candidate should have minimum 6 years of labelling experience in US, Canada, Europe or ROW market

At Apotex, we are committed to fostering a welcoming and accessible 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.