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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!

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

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Pursue Progress. Discovery Extraordinary.

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