Sanofi Group Regulatory Deputy Director North American Business Unit in Toronto, Ontario
Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against over 20 infectious diseases.
This position is within the Regulatory Affairs North American Business Unit. The successful candidate will sit in Toronto, Canada.
This position will have two primary responsibilities: 1.) to coordinate and manage all CA based licensed and pre licensure submission activity for the Canadian Health Authorities and/or US FDA. This individual will also work in partnership with all levels of organization including the Global Business Unit, CMC, Industrial Affairs, Planning, Labeling, Regulatory Affairs Operations to assure all submission milestones are met in a timely manner. 2.) This position will also have primary responsibility of partnering with Commercial Operations to maintain an uninterrupted supply of vaccines within Canada.
This position will manage a small team of direct reports.
A successful candidate will ensure preparation and coordination of the components of the submission within pre-defined schedules in accordance with relevant RA procedures, tools, and templates, and facilitates the final submissions to regulatory authorities and/or third parties.
May need to anticipate delays in pre-defined submissions determine the root cause and facilitate a corrective action plan and/or propose an alternate solution.
This individual may also be asked to organize and function as the lead contact with regulatory agencies or third parties and is responsible for the notification and inclusion of the most appropriate individuals within the company based upon the criticality of the issues to be addressed. In addition, this individual may need to participate in product project teams and develop regulatory strategy for their respective products and projects.
This position will report directly to the Head of the North American Business Unit within Regulatory Affairs.
BA/BS required. MS in Biology, Life Science or related field of study preferred.
2-4 years of applicable regulatory affairs experience.
Candidate should be a self-driven individual with skill in organization, building working relationships and communication. Proven examples of partnering with colleagues to achieve common goals are required. Experience leading Project teams preferred.
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.
Sanofi, Empowering Life
Sanofi, Empowering Life