Senior Director, Regulatory Affairs - Canada
Toronto, Canada, Ontario, M1B2K9
Who we are
The opportunity
Senior Director, Regulatory Affairs Canada
Toronto, Ontario
Hybrid
As Senior Director, Regulatory Affairs Canada, you will lead the strategic direction and execution of regulatory activities across Teva Canada’s full pharmaceutical portfolio, including generic, biosimilar and innovative (specialty) products. You will oversee the development and implementation of regulatory strategies for new product submissions, lifecycle management, and market access, ensuring compliance with Health Canada regulations and alignment with global regulatory standards. This role requires strong leadership, cross-functional collaboration, and the ability to influence regulatory outcomes that support both operational excellence and long-term business growth.
How you’ll spend your day
Strategic Leadership:
- Define and drive regulatory strategies for both generic and innovative submissions, including complex biologics, biosimilars, and specialty products. Ensure alignment with corporate goals and Health Canada requirements.
Team Leadership & Development:
- Lead, mentor, and develop a high-performing regulatory team with expertise across product types. Foster a culture of accountability, innovation, and continuous improvement.
Regulatory Oversight:
- Oversee the preparation and submission of high-quality regulatory dossiers (e.g., ANDS, NDS, CTA, BLA) and responses to Health Canada. Ensure timely, compliant, and strategic submissions.
Cross-Functional Collaboration:
- Partner with Global R&D, Clinical, Medical Affairs, Operations, Quality, and Commercial teams to provide regulatory guidance throughout the product lifecycle.
Compliance & Risk Management:
- Monitor regulatory changes and assess their impact on both generics and innovative portfolios. Ensure proactive risk mitigation and compliance with evolving Health Canada guidelines.
- All other duties as assigned.
Your experience and qualifications
- Education Required:Required: Bachelor’s degree in a science-related field. Preferred: Master’s or advanced degree in Regulatory Affairs, Pharmaceutical Sciences, or a related discipline.
- Required: Minimum 10 years in Regulatory Affairs within the pharmaceutical industry, with at least 5-7 years in a leadership role. Preferred: Experience in both generic and innovative product regulatory strategy, including Health Canada submissions for ANDS, NDS and CTAs.
- In-depth understanding of the pharmaceutical industry, including both generic and innovative specialty markets.
- Familiarity with Health Canada laws, regulations, and current regulatory initiatives.
- Ability to see the big picture and align regulatory strategies with long-term business goals.
- Proven ability to inspire, mentor, and develop high-performing teams.
- Skilled in managing change and fostering a culture of accountability and innovation.
- Strong influencing skills to drive alignment across cross-functional teams and with regulatory authorities.
- Ability to advocate effectively for regulatory positions internally and externally.
- Exceptional written and verbal communication skills tailored to diverse audiences (e.g., Health Canada, executive leadership, global teams).
- Strong interpersonal skills to build trust and partnerships across departments and with external stakeholders.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment