Reference No. R2824249

Position Title: Regulatory Affairs Project Leader

Department: Regulatory Affairs

Location: Toronto, Ontario

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.

Responsible for the Regulatory Affairs (RA) project management of development and marketed products.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Provide regulatory strategic and operational input to local and global teams for development and marketed products throughout their lifecycle
• Develop and execute filing strategies, including assessing and summarizing scientific and clinical information, where applicable
• Organize and coordinate meetings with Health Canada
• Ensure the preparation of high-quality regulatory submissions in alignment with internally defined strategies to meet agreed upon timelines and in compliance with Health Canada Regulations
• Participate in cross-functional meetings with internal stakeholders (locally and globally), providing subject matter expert input on product strategies
• Ensure the ongoing compliance for marketed products, specifically through product monograph and label updates/revisions
• Review and approve promotional and non-promotional material in accordance with regulatory requirements
• Maintenance of internal databases in timely manner as required for portfolio of products

About You

EDUCATION

• BSc., or an equivalent degree in a health-related field

EXPERIENCE

• Minimum of 2-3 years of experience in Regulatory Affairs

SPECIFIC SKILLS AND/OR COMPETENCIES

• Demonstrated success in a regulatory environment (e.g., leading a major submission)
• Good knowledge of the current Health Canada regulations and PAAB guidelines
• 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)
• Able to manage and influence key stakeholders
• Fosters innovation (i.e., embraces new insights, concepts, trends & processes)
• Works well independently as well as in a group environment

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

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

This position is for a current 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.