Regulatory Affairs Manager

Regulatory Affairs Manager Hybrid - 3 days on-site

Scarborough, Ontario

The Regulatory Affairs Manager leads Canadian regulatory planning and execution for generic medicines, including all dosage forms, complex generics, and drug–device combination products. This role provides regulatory strategy, oversees submissions to Health Canada, supports launch preparation, and partners closely with global regulatory affairs, R&D, project management and other stakeholders to guide activities related to the preparation and maintenance of files submitted to Health Canada. The Manager is responsible for developing and implementing regulatory strategies for new products to support timely launch.

How You’ll Spend Your Day

Lead preparation, submission and maintenance of

Abbreviated New Drug Submissions (ANDSs)

and

Supplemental Abbreviated New Drug Submissions (sANDSs) .

Ensure timely updates to product labelling materials, includi...