Head, Regulatory Affairs, General Medicine and Vaccines

Reference No.R2818570

Position Title: Head, Regulatory Affairs, General Medicine and Vaccines

Department: Regulatory Affairs

Location: Toronto, ON

Posting Date: Friday, August 15, 2025

Closing Date: Monday, September 1, 2025

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

The primary purpose of this position is to provide leadership to a team of regulatory professionals for regulatory affairs activities including early approvals and regulatory compliance activities throughout the entire product lifecycle for a portfolio of development and marketed prescription products, as defined by Head, Regulatory Affairs. 

This position may also be a designated back-up to the Head, Regulatory Affairs

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

Regulatory Activities and Resources (60%)

• Provide leadership and managerial support to submissions teams to ensure quality decisions and timely preparation of submissions to Health Canada in order to achieve the shortest time to approval and the best possible labelling. The portfolio supports products in the General Medicine and Vaccines Business units.

• Ensure team maintains compliance (as per Global Regulatory Affairs performance timelines) to provision of current and accurate data in internal database systems

• Evaluate business development opportunities in order to assess optimal regulatory strategy

• Provide strategic direction and leadership in the management of clinical trial regulatory activities for defined portfolio

• Participate in Business Unit (as assigned by Head, Regulatory Affairs) cross-functional leadership team(s) to ensure strategic leadership and contribution from regulatory affairs to core business activities

• As part of RA Leadership team, assist Head, Regulatory Affairs in setting strategic direction for team and ensuring smooth daily operations

Regulatory Resources:

• Ensure and maintain visibility and excellence of the team within business units by developing good scientific skills in the core therapeutic areas

• Maintain awareness and knowledge of new and emerging local and international (EU and US) regulatory trends as well as on basic regulatory quality Canadian requirements

• Review and provide comments on Health Canada draft guidelines and policies.

Development of Human Capital (20-30%):

Direct Reports:

• Ensure implementation of departmental vision and strategies into individual priorities and goals

• Provide constructive feedback and coaching to all direct reports on an ongoing basis to facilitate and enable the attainment of employees’ development plans

• Complete performance review activities for all direct reports as per the established corporate guidelines and practices

Self-Development:

• Elaborate and implement a personal development plan that will allow for the attainment of personal goals and required competencies aligned to the corporate values and priorities

Networking (10-20%):

• Establish and maintain a network with the key corporate regulatory sites and business units to assure the successful execution and alignment of Canadian-specific strategies within an international corporate context

• Develop, optimize and maintain a network with key partners including the Canadian regulatory authority and key opinion leaders and seize opportunities to negotiate improved regulatory processes with the Canadian authority

• Act as Sanofi liaison to industry advocacy external groups such as BIOTECanada or Innovative Medicines Canada (IMC), as required

About You:

Education:

• Minimum Bachelor’s degree in science or a degree in a health-related field

Experience:

•  At least 5 years of experience in regulatory affairs, as a project leader or in another related position and extensive knowledge of the regulatory environment

Specific skills and/or competencies:

• Leadership and managerial skills (strong decision-making, communication, project management and risk analysis skills)

• Building effective teams

• Developed change leadership skills (i.e., ability to cope with and adapt to change, effectively prioritize, and deal with ambiguity)

• Strong strategic and operational thinking (i.e., able to think big picture balanced with strong analytical skills)

• Excellent negotiation skills with demonstrated ability to manage and influence key stakeholders

• Fosters innovation (i.e., embraces new insights, concepts, trends & processes)

Languages

•  English (written and spoken)

• French is an asset

Computer knowledge

•  MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat, Veeva Vault database familiarity is an asset 

Travel

•  Occasional

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs

Applications received after the official close date will be reviewed on an individual basis. This position is for a new vacant role that we are actively hiring for.​

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

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