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Ensure compliance of insulin API products with Chinese and international regulations through the authoring of dossiers and variations. Coordinate with global regulatory teams to support product registration and health authority interactions during facility construction and validation.
Requires a degree in Science or Pharmacy, preferably an MSc, with 3-5 years of experience in biopharma regulatory affairs. Must possess in-depth knowledge of NMPA, FDA, and European regulatory requirements and be fluent in both English and Chinese.
About the job
Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. The new facility will be designed as a fully automated, green, modern, and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing.
Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. Watch now!
Position Overview
The Regulatory Site Officer-IFB ensures compliance of Beijing insulin API products with all relevant product registrations, laws, regulations, standards, and guidelines, with focus on IFB China related requirements. This position supports authoring dossiers, variations, CTD sections impacted by changes, and renewals of product registrations in compliance with all applicable regulations and company processes. The role will coordinate with China country regulatory affairs&CMC regulatory, Global regulatory affairs&CMC regulatory-InsuLINK, support IFB regulatory strategy development, health authority interactions.
This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval.
Main responsibilities:
Core Regulatory Activities:
Quality and Project Support:
About you
Experience
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!
We are an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Interactions with this account must comply with the Terms: https://bit.ly/sanofi-terms
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There are currently 474 open engineering positions in Beijing, China listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include NVIDIA, Danaher, Applied Materials, Sanofi, Hitachi Energy, among others. Browse the listings above to see every active employer.
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