Lead Regulatory Site Officer Insulink (All Genders)

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 jobBe 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!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 ResponsibilitiesLead 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 CMCEnsure 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 licensedAuthor 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 siteDefine 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 approvalMonitor 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 levelManage the writing and maintenance of Site Master Files for both InsuLINK facilities and oversee all regulatory aspects of product lifecycle managementLead GMP health authority interactions including inspection preparations, coordination, responses to queries, and follow-ups with BfArM, NMPA, FDA, and Health CanadaOversee 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 StandardsProvide regulatory support for quality systems implementation, GMP compliance, and C&Q&V strategy across both facilities, while fostering quality culture and mindset throughout the projectCoordinate with Global Regulatory CMC to ensure alignment of regulatory strategies, maintain best practices cross-fertilization, and ensure consistency across Sanofi's regulatory approachesAbout youExperience: 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 complianceSoft 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 performanceEducation: Degree in Science/Pharmacy or Equivalent (MSc or PhD preferred)Languages: Proficiency in English is required;

knowledge of German andChinese is highly desirable