Regulatory Affairs Manager

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Our Team, Your Impact

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 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.

How You’ll Spend Your Day

• Lead preparation, submission and maintenance of:

• • Abbreviated New Drug Submissions (ANDSs)
  • 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

Your Skills and Experience

• Required: 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 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

How We’ll Take Care of You

At Teva Canada we provide a rewarding and collaborative work experience, with career growth and development opportunities for employees, in a safe and caring environment!  The typical hiring range for this position is $99,200-$124,000.  The base pay offered 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 also offers a comprehensive suite of wellness and benefits programs tailored to role and employment type, that continue to rank among the best in our industry! Our competitive offerings are designed to provide flexibility, security, and meaningful choices, empowering employees to thrive both personally and professionally throughout their journey with us. 

As part of our commitment to well-being, employees may have access to:

• Teva Canada’s choices Benefit Plan including Health, Dental, Disability, Life Insurance
• Employee Assistance Program & Virtual Health Programs
• Retirement Savings Programs
• Employee Stock Purchase Plan (ESPP)
• Time for yourself or those you care about, through 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
• And much more! 

More exciting details on the specific total rewards offerings to be provided at the offer stage depending on the position and employment type hiring for. This position will fill a current vacancy and Teva Canada may use an artificial intelligence (AI) system to assist with the initial screening and evaluation of job applications by analyzing for relevant skills, professional experience, and education, that best match the posted job qualifications. It is important to note that all final decisions in this process are made by a member of the hiring team.

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