Regulatory Affairs ManagerHybrid - 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.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 with Pharmacovigilance requirements by reporting safety information to the Teva Pharmacovigilance team as per required training.Communicate regulatory intelligence, 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.Your Skills and ExperienceRequired: Bachelor’s degree in a science‑related field. Preferred: Master’s degree in a science discipline.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 ability to work independently as well as in a team environment.Leadership skills 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.How We’ll Take Care of YouThe typical hiring range for this position is $99,200–$124,000. The base pay may vary depending on job‑related knowledge, skills, experience, education, and internal equity. In addition to base salary,



this role may qualify for an annual bonus based on employment type. Certain positions may also be eligible for a sales commission structure as part of the overall compensation package.Beyond base pay, Teva offers a comprehensive suite of wellness and benefits programs tailored to role and employment type.Employees may have access to:Teva Canada Benefit Plan including Health, Dental, Disability, Life Insurance.Employee Assistance Program and 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.Teva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva’s global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job prospect, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.EOE including disability/veteran#J-18808-Ljbffr

📌 Regulatory Affairs Manager - C$99,200 - C$124,000 A Year (Winnipeg)
🏢 Teva Pharmaceuticals
📍 Winnipeg