Head, Regulatory Affairs, General Medicine and Vaccines Canada

Reference no. R2859308

Position title: Head, Regulatory Affairs, General Medicine and Vaccines Canada

Department: Regulatory Affairs

Location: Toronto, ON

About the job

As the Head, Regulatory Affairs, General Medicine and Vaccines Canada on our GRA NA team, you’ll be fully accountable 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. Ready to get started?

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

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.

About Sanofi 

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. 

Our Team/ Overview:

The Canada Regulatory Affairs team is responsible for preparing and submitting regulatory dossiers to Health Canada to ensure regulatory compliance and obtain marketing authorizations for Sanofi's General Medicine, Specialty Care, and Vaccine portfolio products. The team serves as the direct point of contact with Health Canada, coordinating regulatory submissions, responding to authority questions, and maintaining commitments to support timely product approvals.

Main Responsibilities:

1.     Accountable for the activities of a team of professional level individuals, that cover a portfolio (as defined by Head, Regulatory Affairs) of development and marketed products –80-90% of allocated time

a) Regulatory Activities and Resources –60% of allocated time

• 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.

b)     Development of Human Capital – 20-30% of allocated time

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

2.     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 / Knowledge:

• 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 important asset

Computer Knowledge:

• MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat

• Veeva Vault database familiarity is an asset

Travel:

• Occasionally

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. 

Pourquoi nous choisir ? 

• Donnez vie aux miracles de la science au sein d'une équipe solidaire et tournée vers l'avenir 
• Découvrez les innombrables possibilités de développer vos talents et de faire progresser votre carrière, que ce soit par le biais d'une promotion ou d'une cooptation, dans votre pays ou à l'étranger. 
• Profitez d'un ensemble d’avantages bien pensés et bien conçus qui reconnaissent votre contribution et amplifient votre impact. 
• Prenez bien soin de vous et de votre famille en bénéficiant d’un large éventail d'avantages en matière de santé et de bien-être, y compris des soins de santé de haute qualité, des programmes de prévention et de bien-être \

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.

Toute compensation sera déterminée en fonction de l'expérience démontrée. 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.