Regulatory Site Officer

R2853492 Regulatory Site Officer

Department: Regulatory Site Office

Location: Toronto, ON

Grade: L2

About the Job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

The Quality Compliance and Regulatory Team is part of Site Quality Operations supporting the Manufacturing & Supply organization in Toronto. The Quality Compliance and Regulatory teams oversee site compliance programs, self-inspection, quality risk management and regulatory dossier management (chemistry, manufacturing & controls and facilities) in alignment with regulatory requirements and Sanofi standards.

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

Main Responsibilities:

• Authoring variations, CTD sections impacted by the changes and the renewals for registered products, territory extensions, in compliance with all applicable regulations and company processes.
• Maintaining and updating regulatory files and databases.
• Define the potential regulatory impacts of changes made to a group of products and services.
• Ensuring compliance of a group of products with all relevant product registrations, laws, regulations, standards, and guidelines in the markets where the site operates.
• Support regulatory inspections and audits, providing regulatory support and documentation.

Key Roles

• Advise how to write CMC dossiers and responses to health authority queries.
• Decide for which changes a regulatory strategy must be established and provide the information to site operations.
• Review regulatory strategies defined by GRA for changes linked to site products.
• Advise and execute the regulatory compliance maintenance program for the site products.
• Advise on audit preparation and follow-up action

About You

• Minimum of a bachelor’s degree; advanced degree (Masters, PhD) in a science/health field is preferred.
• At least 2-4 years of Regulatory Affairs CMC experience, or combination of experience in a Quality role, in the pharmaceutical/biologics industry.
• Experience working for a Regulatory Health Authority an asset.
• Strong verbal and written communication skills to prepare accurate, clear, and comprehensive CMC dossiers; able to effectively communicate with internal and external audiences.
• Self-motivated, detail oriented and results driven with excellent organizational ability.
• Strong site and customer focus with ability to prioritize/adapt to changing business and manufacturing needs.
• Strong problem-solving skills with ability to overcome risks/constraints.
• Strong self-awareness and ability to understand role's impact/influence, as well as decision making ability.

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.

AI Usage

"Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal, Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint.

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.

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.