R&D
Wo deine Neugier die Wunder der Wissenschaft antreibt

R2827710 Regulatory Affairs Coordinator

Location: Toronto, Canada

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. 

The Regulatory Affairs (RA) Coordinator is the RA department Subject Matter Expert (SME) for financial systems [Health Canada (HC) invoice fees processing, assisting with HC submission fees budgeting, setting up vendor and consultant contracts and purchase orders].  Acts as the department Business Archives Coordinator (BAC) and maintenance of offsite archives. Lead to assess and assign department training, as well as coordinate workflow of and support development of local department work processes. Coordinate translation process and ensure current Canadian patent information maintained.

This position also has general administrative duties, including monitoring of the group mailbox and coordination of meetings and other operational activities within the regulatory department.

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:

• Process all Health Canada and other Regulatory Department invoices on a timely basis. Independently work to trouble-shoot any Health Canada invoice issues. 

• Assist with budget planning of health authority submission fees (approximately $5 million Canadian) by tracking expected submission workload

• Set up new / extend current contracts and purchase orders with third-party vendors; track monthly accruals

• Key user for inhouse tools such as Coupa (finance) and Arpeges (records management)

• Monitor group mailbox and electronically file all Health Canada correspondence in internal database systems (eg Vault). SME for health authority correspondence filing, independently providing all meta-data information and linking to appropriate submissions. 

• Document policies, procedures and workflow for assigned areas of responsibility

• Coordinate translation process

• Maintain current Canadian patent information

• Lead in assignment of training to all Regulatory Affairs members and maintenance of current training curriculum

• Accurately complete and file Annual Drug notification forms (to Health Canada), coordinate CPS (Compendium of Pharmaceuticals and Specialties) listings (external publisher)

• Contribute to department and organization special projects as assigned

About You

• Office Administration Diploma with 2 years of experience, OR Bachelor's degree with 1 year of experience

• Advanced proficiency in Microsoft Office Suite and strong computer skills

• Excellent organizational abilities with keen attention to detail and deadline-driven mindset

• Strong written and verbal communication skills with effective interpersonal abilities

• Demonstrated ability to prioritize tasks and adapt to changing requirements

• Capable of working both independently and collaboratively in a team 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 new 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.

Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.