Head, Regulatory Affairs, General Medicine and Vaccines
Job Description
Description
Head, Regulatory Affairs, General Medicine and Vaccines
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Head, Regulatory Affairs, General Medicine and Vaccines
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This range is provided by Sanofi. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
CA$125,300.00/yr – CA$180,966.66/yr
Reference No .R
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
Education
About You:
- 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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Les employés peuvent être admissibles à participer aux programmes d’avantages sociaux de l’entreprise. Des informations supplémentaires sur les avantages sociaux peuvent être trouvées ici.
Pursue Progress . Discover Extraordinary .
Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
Seniority level
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Seniority level
Director
Employment type
-
Employment type
Full-time
Job function
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Job function
Legal
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Industries
Pharmaceutical Manufacturing
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Company
Sanofi
Location
Mississauga
Country
Canada
Salary
125.000
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