At a Glance
- Tasks: Lead a team in regulatory affairs for innovative medicines and vaccines.
- Company: Join Sanofi, a cutting-edge biopharma company focused on improving lives.
- Benefits: Enjoy competitive salary, health benefits, and opportunities for career growth.
- Other info: Dynamic work environment with a focus on innovation and personal development.
- Why this job: Make a real impact in healthcare while working with a supportive team.
- Qualifications: 5+ years in regulatory affairs with strong leadership and strategic skills.
The predicted salary is between 20000 - 208200 $ per year.
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.
The Canada Regulatory Affairs team is responsible for preparing and submitting regulatory dossiers to Health Canada to ensure regulatory compliance and obtain marketing authorisations 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
- Accountable for the activities of a team of professional level individuals, that cover a portfolio of development and marketed products.
- Provide leadership and managerial support to submissions teams to ensure quality decisions and timely preparation of submissions to Health Canada.
- Ensure team maintains compliance 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 cross-functional leadership team(s) to ensure strategic leadership and contribution from regulatory affairs to core business activities.
- Assist Head, Regulatory Affairs in setting strategic direction for team and ensuring smooth daily operations.
Development of Human Capital
- 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.
- 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
- Establish and maintain a network with the key corporate regulatory sites and business units.
- Develop, optimise and maintain a network with key partners including the Canadian regulatory authority.
- Act as Sanofi liaison to industry advocacy external groups 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.
- Specific Skills / Knowledge: Leadership and managerial skills, strong decision-making, communication, project management and risk analysis skills.
- 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 recognises 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 programmes.
Head, Regulatory Affairs, General Medicine and Vaccines in Toronto employer: Sanofi
As a leading global biopharmaceutical company, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to make a meaningful impact in the field of healthcare. With a strong focus on professional development and growth opportunities, our team members are encouraged to expand their expertise while contributing to transformative patient care solutions. Enjoy the flexibility of a remote position combined with the excitement of engaging with healthcare professionals across the country, all while being part of a mission-driven organization dedicated to improving lives.
