**Reference No.** R2832279 **Position Title:** Head, Regulatory Affairs, Chemistry and Manufacturing Controls (CMC), Specialty Care and General Medicine, Canada **Department:** Regulatory Affairs **Location:** Toronto, ON **About the Job:** Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. The primary purpose of this position is to provide leadership to a team of regulatory CMC (Chemistry, Manufacturing & Controls) professionals. Specifically, the position supervises the successful execution of product development and regulatory compliance activities pertaining to CMC throughout the product lifecycle for all development and marketed products in the General Medicine and Specialty Care portfolios (sanofi-aventis), through the efficient management of CMC processes and resources. This position may also be a designated back-up to the Head, Regulatory Affairs. **About Sanofi:** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. **Main Responsibilities:** **1) Accountable for the activities of a team of professional level individuals, that cover all development and marketed products (80-90% of allocated time)** A) Regulatory Activities and Resources (60% of allocated time): + Assure optimal Canadian regulatory input into the Global RA CMC working groups in line with strategies defined for Canadian RA + Provide leadership and managerial support to CMC submissions teams to ensure quality decisions and timely preparation of submissions in order to achieve the shortest time to approval and the target CMC profile + Planning and coordination of all submissions involving a CMC component within agreed timelines + Ensure that the content of technical documents needed to support RA CMC submissions complies with Canadian standards. + Assure the accuracy of all CMC information contained within regulatory documentation authored by the RA CMC team + Assess and assure adequate reporting to necessary authorities as per current regulatory and legal requirements for CMC changes + Ensure compliance to CEPA (Canadian Environmental Protection Act) and timely filing of New Substances Notification + Ensure team maintains compliance (as per Global Regulatory Affairs performance timelines) to provision of current and accurate data in internal database systems + For the evaluation of new business opportunities and due diligence, provide CMC scientific advice and assessment + As part of RA Leadership team, assist Head, Regulatory Affairs in setting strategic direction for team and ensuring smooth daily operations + Regulatory Resources: + Support the development of CMC expertise of employees in the Regulatory Affairs team + Maintain awareness and knowledge of new and emerging local and international (EU,US, ICH) regulatory trends as well as on basic regulatory safety and efficacy Canadian requirements + Review and provide comments on CMC related HC draft guidelines and policies B) Development of Human Capital (20-30% of allocated time): + Direct Reports: + Ensure implementation of departmental vision and strategies into individual priorities and goals + Provide constructive feedback and coaching to all direct reports on an ongoing basis to facilitate and enable the attainment of employees’ development plans + Complete performance review activities for all direct reports as per the established corporate guidelines and practices + Self-Development: + Elaborate and implement a personal development plan that will allow for the attainment of personal goals and required competencies aligned to the corporate values and priorities **2) Networking (10-20% of allocated time)** + Establish and maintain a network with the key corporate regulatory sites and business units to assure the successful execution and alignment of Canadian-specific strategies within an international corporate context + Develop, optimize and maintain a network with key partners including the Canadian regulatory authority and key opinion leaders and seize opportunities to negotiate improved regulatory processes with the Canadian authority + Act as Sanofi liaison to industry advocacy external groups such as BIOTECanada or Innovative Medicines Canada (IMC), as required **About You:** **Education:** + Minimum Bachelor’s degree in any relevant science related field (e.g. chemistry, biochemistry, pharmaceutical sciences) **Experience:** + At least 5 years of experience in CMC Regulatory Affairs, as a project leader; extensive experience and knowledge of pharmaceutical research and development processes and of the regulatory environment **Specific Skills and/or Competencies** + Must have Excellent knowledge of Regulatory Affairs, more specifically in the field of CMC + Leadership and managerial skills + Strategic agility + Building effective teams + Excellent communication skills + Strong decision-making skills + Excellent negotiation skills + Strong Project Management Skills + Good risk analysis skills **Languages** + English (written and spoken) + French is an important asset **Computer Knowledge** + MS Outlook, PowerPoint, Word, Excel, Adobe Acrobat **Travel** + Occasionally **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 (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) ! _North America Applicants Only_ The salary range for this position is: $125,300.00 - $180,966.66 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 (https://myflex-benefits.ca/en/home/) . La fourchette salariale pour ce poste est la suivante: $125,300.00 - $180,966.66 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 (https://myflex-benefits.ca/fr/home/) . 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)