Job Description
Regulatory Affairs Manager
Hybrid - 3 days on-siteScarborough, OntarioThe 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 DayLead preparation, submission and maintenance ofAbbreviated New Drug Submissions (ANDSs)andSupplemental Abbreviated New Drug Submissions (sANDSs) .Ensure timely updates to product labelling materials, including safety updates to product monographs, associated with regulatory filings.M...
Hybrid - 3 days on-siteScarborough, OntarioThe 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 DayLead preparation, submission and maintenance ofAbbreviated New Drug Submissions (ANDSs)andSupplemental Abbreviated New Drug Submissions (sANDSs) .Ensure timely updates to product labelling materials, including safety updates to product monographs, associated with regulatory filings.M...