Regulatory Affairs Manager

Teva Pharmaceuticals • Toronto, ON

8d • Hybrid

About The Position

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 internal and external stakeholders to guide activities related to the preparation and maintenance of files submitted to Health Canada. The Regulatory Affairs Manager is responsible for developing, coordinating, and implementing regulatory strategies for new products to support timely launch.

Requirements

• Bachelor’s degree in a science‑related field.
• 5 years + of experience in the pharmaceutical industry
• Strong background in regulatory strategy and Health Canada submissions
• Experience with sterile products, complex generics, biosimilars, and drug–device combination products
• Proficiency in Microsoft Office applications
• Strong interpersonal skills and the ability to work independently as well as in a team environment
• Leadership skills in managing submissions and projects with multidisciplinary local and global teams
• Knowledge of Health Canada laws and regulations
• Understanding of Health Canada guidances and evolving regulatory initiatives
• Global jurisdictions and ICH knowledge
• Solid scientific and analytical skills
• Working knowledge of Health Canada guidelines
• Priority‑driven, team‑oriented, and goal‑focused approach
• Ability to manage multiple priorities in a matrixed environment

Nice To Haves

• Master’s degree in a science discipline

Responsibilities

• Lead preparation, submission and maintenance of Abbreviated New Drug Submissions (ANDSs) and Supplemental Abbreviated NDSs (sANDSs)
• Ensure timely updates to product labelling materials, including safety updates to product monographs, associated with regulatory filings
• Manage deficiency responses and timelines of submissions under review
• Participate in regulatory meetings (pre-submission, dossier compilation)
• Act as the Canadian regulatory lead on global and local project teams
• Ensure compliance to the Pharmacovigilance requirements by reporting any safety information to Teva Pharmacovigilance team as per required training
• Communicate regulatory intelligence and review and comment on Health Canada’s evolving guidelines
• Ensure adherence to Canadian regulations, ICH guidelines and internal SOPs
• Monitor regulatory landscape and assess impact on development programs and marketed products.
• Contribute to process improvements and best practices within the Regulatory Affairs function.
• Other Duties as assigned

Benefits

• Health, Dental, Disability, Life Insurance
• Employee Assistance Program & Virtual Health Programs
• Retirement Savings Programs
• Employee Stock Purchase Plan (ESPP)
• Paid time for Vacation, Wellness days, Care/Sick days, Teva Days and Volunteer Days
• Education Assistance Program
• Recognition programs such as Employee Service Awards
• Employee Discounts

What This Job Offers

• Job Type: Full-time
• Career Level: Manager