Regulatory Affairs Coordinator at Sanofi Aventis US LLC

Mississauga, Ontario, Canada -

Full Time

Start Date

Immediate

Expiry Date

29 Jan, 26

Salary

72999.0

Posted On

31 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Office Administration, Budget Planning, Contract Management, Invoice Processing, Communication Skills, Organizational Skills, Microsoft Office Suite, Team Collaboration, Attention to Detail, Training Coordination, Translation Process, Database Management, Problem Solving, Meta-Data Management, Health Canada Regulations

Industry

Pharmaceutical Manufacturing

Description

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. #GD-SG #LI-GZ #LI-Onsite 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. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! North America Applicants Only The salary range for this position is: $50,538.00 - $72,999.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK. La fourchette salariale pour ce poste est la suivante: $50,538.00 - $72,999.33 Toute compensation sera déterminée en fonction de l'expérience démontrée. Les employés peuvent être admissibles à participer aux programmes d'avantages sociau de l'enterprise. Des informations supplémentaires sur les avantages sont disponibles via le lien. Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The Regulatory Affairs Coordinator processes Health Canada invoices and assists with budget planning for submission fees. They also coordinate training and maintain departmental records and correspondence.