About the jobOur TeamYou are keen on learning just everything about the manufacturing, packaging, testing and supply of Biological Products? Become an ambassador for the Chemistry, Manufacturing and Control processes at the Sanofi manufacturing site Frankfurt / Germany to Health Authorities in > 180 countries worldwide. Connect the dots in this highly transversal position and join our mission to open the gate to the market for life-saving biological drugs by obtaining and maintaining of regulatory applications.About SanofiWe’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 responsibilitiesEnsure regulatory compliance by assessing whether manufacturing and control procedures on site are in line with dossiers approved by Health AuthoritiesAssessment of and decision on regulatory impact of product-related changesManage regulatory site activities for changes with regulatory impact by organization of site meetings and participation in global meetingsSupport QA functions for implementation of changes by cross-functional communication of regulatory timelines and approval statuses worldwideProvides regulatory expertise to site projects like the introduction of new products, process technologies and continuous improvement projectsSupport change management of transfer projects by providing regulatory expertise for available product dossiersWrite CMC regulatory documents/dossiers ready for submission by transforming scientific content to consistent CMC language and optimized terminology to facilitate the management of future changesSupport Marketing Authorizations worldwide (territory extensions, renewals, site registrations and transfers, new submissions) by providing CMC documents/dossiers and collecting GMP related documents from the site(s)Coordinate and follow up submission-related regulatory requests following dossier variations or new registrationsPrepare with contribution of site experts answers to questions from Health AuthoritiesAct as interface to Global or Affiliate Regulatory Affairs for QA or Manufacturing functions of the siteCollaborate in creation and maintenance of standard operation procedures with regulatory contextContribute to and support continuous improvement of performance and efficiency of regulatory working processesSupport preparation of inspections and audits and participate as subject matter expert in audits/inspectionsApply and optimize the use of appropriate company software tools to manage all regulatory activitiesAbout youExperience: Technical pharmaceutical CMC experience (laboratory, manufacturing, analytical control etc.) is desirable. Typically, at least 1-5 years of direct Regulatory CMC experience is preferred. Knowledge of global regulations/guidelines and key Health Authority and Industry trends of advantageSoft skills: Capability of strategic thinking for resolving technical and regulatory issues. Demonstrate initiative, independent thinking, anticipatory foresight, and ability to communicate effectively to internal and external audiences. Ability to make decisions in a highly moving environmentTechnical skills: Knowledge of both Chemical and Biological products is a plus. Skills for handling of internal data management systems and documentation toolsEducation: Ph.D or Master in a science/health field (e.G. Chemistry, Pharmacy, Pharmacology, Biology, Biotechnology etc.) or equivalentLanguages: Fluency (oral and written) in German and English language is strongly recommendedWhy choose us?Bring the miracles of science to life alongside a supportive, future-focused teamDiscover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationallyBenefit from a well-thought-out benefits package that rewards your contribution and commitmentStart your career at an attractive location in the center of Germany and experience our modern working environment and benefit from hybrid, flexible working time models