Regulatory Affairs Manager

The opportunity

Regulatory Affairs Manager

Location: Montreal, Quebec

Hybrid, 3 days on site

The Regulatory Affairs Manager leads Canadian regulatory planning and execution for innovative medicines (biologics, biosimilars and small molecules). This role provides strategic direction for clinical development programs, oversees Health Canada’s submissions, and partners closely with Global Specialty Regulatory Affairs, the TCI cross functional team and with R&D to support the strategic direction on activities related to the preparation and maintenance of the files submitted to the Canadian Federal Government. The professional will be responsible for developing, coordinating, and implementing regulatory strategies for new products and marketed product registrations.

How you’ll spend your day

• Lead the preparation, submission, and maintenance of: Clinical Trial Applications (CTAs) New Drug Submissions (NDSs) Supplemental NDSs (SNDSs) Lifecycle and maintenance activities for marketed products
• Ensure timely updates to product labelling, including safety‑related changes to product monographs.
• Review training materials, advertising, and promotional content for regulatory compliance.
• Ensure adherence to pharmacovigilance requirements by reporting safety information to Teva’s PV team.
• Lead regulatory meetings with Health Canada (pre‑CTA, pre‑submission, etc.).
• Serve as the Canadian regulatory lead on global and local project teams.
• Monitor and interpret regulatory intelligence; assess the impact of evolving Health Canada guidelines.
• Ensure compliance with Canadian regulations, ICH guidelines, and internal SOPs.
• Contribute to process improvements and best practices within the Regulatory Affairs function.

Your experience and qualifications

• Bachelor’s degree in a science‑related field. Master’s degree in a scientific discipline preferred.
• Minimum 5 years of experience in the pharmaceutical industry
• Strong background in clinical regulatory strategy and Health Canada submissions
• Minimum 5 years of experience with specialty products (biologics, biosimilars, pharmaceuticals)
• Proficiency in Microsoft Office applications
• Strong interpersonal skills; able to work independently and collaboratively
• Demonstrated leadership in managing submissions and cross‑functional projects
• Solid scientific and analytical skills
• Strong understanding of Health Canada regulations, guidelines, and evolving initiatives
• Knowledge of global regulatory frameworks and ICH guidelines
• Ability to manage multiple priorities in a matrixed environment
• Organized, team‑oriented, and goal‑driven

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! 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.