Toronto, ON, M5R 1A6, CAN
3 days ago
Global Regulatory Affairs Vaccines Strategist - VIE Contract
**Global Regulatory Affairs Vaccines Strategist - VIE Contract** + _Location_ _:_ _Canada, Toronto_ + _Target start date:_ _01/09_ _/2025_ iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship. PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address. **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._ _Join our Regulatory Affairs team as_ **_Global Regulatory Affairs Vacinnes Strategist VIE_** _and you’ll_ _participate in the missions of the Global Regulatory Affairs Franchise Vaccines Traveler Endemic._ _We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world._ **Main responsibilities:** Global Tasks : + Coordinate regulatory activities to support the Common Technical Documents (CTD) task force, as preparation of pre-submission activities. + Coordinate regulatory activities to support the Global Submission Plan with the global product regulatory team (GRT), track and update Global Simultaneous Submission plan (GSS). + Participate in the preparation of consultations with Authorities. + Support the GRL for the meetings of the global regulatory team (GRT) composed of the different regulatory experts (RegCMC, RegLabeling, Regional Regulatory contacts, Regulatory Operations): preparation, meeting minutes, follow-up of actions. + Support the Global Regulatory Lead (GRL) for the update of the document summarizing the Global Regulatory Product Strategy (GRPS). Specific Country Tasks : + ​Coordinate and contribute to the regulatory activities for dedicated products. + Work with Canadian GRL and RS to support French or US product licensed in CA or CA manufactured products licensed world wide for new market authorizations, line extension presentation or Q&A facilitation, clinical- or Chemistry, Manufacturing and Controls (CMC) labeling variation submissions co-ordination in CA, US and EU markets. **About you** **Experience:** + Previous experience in Regulatory Affairs would be a strong asset. + Experience in the pharmaceutical industry is highly preferred. **Soft and** **Technical** **skills** **:** + Advanced MS Office skills (Excel in particular, Think Cell would be a plus). + ​Good communication, coordination, and facilitation skills. + Great organizational and multitasking skills. + Strong team orientation. **Education:** + Master’s degree in Biology, Life Science, Regulatory Affairs or related field of study. **Languages:** + Proficiency in English. **Why choose us?** iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow. Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work. \#LI-EUR **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) 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 (https://youtu.be/96EwNjb1TLo) 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 (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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