Project Leader, Regulatory Development

Reference No. R2730396

Position Title: Project Leader, Regulatory Development

Department: Development

Location: Hybrid Role based in Toronto, Ontario

About Sanofi – www.sanofi.ca

At Sanofi, we chase the miracles of science to improve people’s lives.  We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

As one of Canada’s leading investors in life sciences, manufacturing and research and development, we focus on delivering new and better ways to address unmet medical needs. Our life-changing and lifesaving products are grounded in science that Canadians can trust. They empower self-care, prevent and treat diseases, and help people live better.

Sanofi Canada operations focus on four therapeutic areas: General Medicines (diabetes, cardiovascular, arthritis, transplant, and thyroid cancer);Specialty Care (rare diseases, rare blood disorders, oncology, immunology, multiple sclerosis);Vaccines (manufactures, formulates, fills, inspects and/or packages vaccines and biologics, protecting against 20 infectious diseases including pertussis, diphtheria, tetanus and influenza); and Consumer Healthcare (pain care, allergy, digestive health, personal care).

Position Summary:

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

Key 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.

Key Requirements:

• BSc. (required), or a degree in a health-related field.

• Minimum of 5-7 years of experience in Regulatory Affairs.

• 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

Travel:

• Occasional

Pursue Progress

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!

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.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

Follow Sanofi on Twitter: @SanofiCanada  and on LinkedIn: https://www.linkedin.com/company/sanofi

#GD-SA #LI-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.