Reference No. R2824249 Position Title: Regulatory Affairs Project Leader Department: Regulatory Affairs Location: Toronto, Ontario 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. Responsible for the Regulatory Affairs (RA) project management of development and marketed products. 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: Provide regulatory strategic and operational input to local and global teams for development and marketed products throughout their lifecycle Develop and execute filing strategies, including assessing and summarizing scientific and clinical information, where applicable Organize and coordinate meetings with Health Canada Ensure the preparation of high-quality regulatory submissions in alignment with internally defined strategies to meet agreed upon timelines and in compliance with Health Canada Regulations Participate in cross-functional meetings with internal stakeholders (locally and globally), providing subject matter expert input on product strategies Ensure the ongoing compliance for marketed products, specifically through product monograph and label updates/revisions Review and approve promotional and non-promotional material in accordance with regulatory requirements Maintenance of internal databases in timely manner as required for portfolio of products About You EDUCATION BSc., or an equivalent degree in a health-related field EXPERIENCE Minimum of 2-3 years of experience in Regulatory Affairs SPECIFIC SKILLS AND/OR COMPETENCIES Demonstrated success in a regulatory environment (e.g., leading a major submission) Good knowledge of the current Health Canada regulations and PAAB guidelines Developed change leadership skills (i.e., ability to cope with and adapt to change, effectively prioritize, and deal with ambiguity) Strong strategic and operational thinking (i.e., able to think big picture balanced with strong analytical skills) Able to manage and influence key stakeholders Fosters innovation (i.e., embraces new insights, concepts, trends & processes) Works well independently as well as in a group 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 current 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-SP #LI-SP #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: $108,900.00 - $157,300.00 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: $108,900.00 - $157,300.00 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
