**To ensure a rapid processing of your application, please apply only via the “Apply” button. Please include a letter of motivation and a current resume with your application.** **_About the job_** Be part of a once-in-a-generation project that’s shaping the future of insulin. Sanofi is building cutting-edge, fully automated insulin drug substance facilities in Frankfurt and Beijing – a bold investment that builds on our legacy of excellence in insulin manufacturing. This sustainable, next-gen biologics sites will support the entire portfolio of insulins. Join us at the forefront of this global transformation. As part of a cross-functional program team, you’ll help bring this facility to life – from early design and construction through to readiness for commercial manufacturing. Your work will help turn the miracles of science into reality for millions living with diabetes. Meet Katrin, our Global Insulin Program Leader, and see how we’re reimagining insulin production. Watch now! (https://youtu.be/b8LsGxV8EA8) We are seeking a highly skilled and experienced **Regulatory Site Officer** for our InsuLINK program. This senior leadership position is vital in ensuring the highest standards of regulatory compliance throughout our state-of-the-art insulin manufacturing facilities in Europe and China. The role involves leading all quality regulatory activities (RSO) for both sites, with a focus on regulatory strategy implementation, CTD writing, health authority interactions, and ensuring BLA and Annex I compliance throughout the entire program lifecycle from feasibility to Process Performance Qualification (PPQ) and final approval. If you are passionate about leading regulatory Quality in the pharmaceutical industry, have a strong background in biologics manufacturing, possess exceptional technical writing skills, and have the leadership capabilities to drive regulatory excellence in a complex, cutting-edge environment, we encourage you to apply for this exciting opportunity. **Main Responsibilities:** + Lead and manage the InsuLINK RSO team, ensuring delivery of all quality regulatory affairs aspects within allocated budget, schedule, and quality objectives while providing regular reporting to the Global Program Quality Head InsuLINK and dotted line reporting to Manager Regulatory CMC. + Ensure compliance of InsuLINK insulin API products with all relevant product registrations, laws, regulations, standards, and guidelines in markets where IFF (Germany) and IFB (China) sites are licensed. + Author and manage CTD dossiers, variations, renewals, and all technical regulatory documentation for InsuLINK product registrations in compliance with applicable regulations, company processes, and interactions with Frankfurt Biocampus and Beijing DP site. + Define regulatory impacts of changes to InsuLINK products and services, and execute the regulatory compliance maintenance program for all site products across the project lifecycle from conceptual design through final approval. + Monitor and anticipate changes in the regulatory environment, maintain regulatory intelligence, and determine impact and implications for InsuLINK facilities while implementing appropriate regulatory procedures at site level. + Manage the writing and maintenance of Site Master Files for both InsuLINK facilities and oversee all regulatory aspects of product lifecycle management. + Lead GMP health authority interactions including inspection preparations, coordination, responses to queries, and follow-ups with BfArM, NMPA, FDA, and Health Canada. + Oversee the quality regulatory affairs budget and schedule, ensuring regular collection of actual project costs and progress while maintaining compliance with Sanofi Cost & Schedule Policies and Standards. + Provide regulatory support for quality systems implementation, GMP compliance, and C&Q&V strategy across both facilities, while fostering quality culture and mindset throughout the project. + Coordinate with Global Regulatory CMC to ensure alignment of regulatory strategies, maintain best practices cross-fertilization, and ensure consistency across Sanofi's regulatory approaches. **_About you_** + **Experience** : significant industry experience, preferably within the biopharmaceutical or related regulated industry with focus on Regulatory Affairs; experience in a leadership position with a proven track record of delivery and compliance + **Soft and technical skills** : In-depth knowledge of the BLA process, Annex I requirements, CTD format, and associated regulatory requirements in US, Europe, and China; Strong technical regulatory writing skills and experience with health authority interactions; Knowledge of GMP and quality systems; Effective coaching skills to develop people and improve performance + **Education** : Degree in Science/Pharmacy or Equivalent (MSc or PhD preferred) + **Languages** : Proficiency in English is required; knowledge of German and Chinese is highly desirable **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)