Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden
Regulatory Site Officer (all genders) - fixed term until 30.06.2027
Auf einen Blick:
Unsere Teams produzieren und liefern jedes Jahr über 4 Milliarden Einheiten an Medikamenten und Impfstoffen und sorgen dafür, dass jede Innovation die Menschen erreicht, die sie am dringendsten benötigen. Unsere hochmodernen Produktionsstätten, KI-gestützten Smart Factories und wegweisenden Automatisierungstechnologien setzen neue Maßstäbe – damit Behandlungen Patient*innen schneller, sicherer und nachhaltiger als je zuvor erreichen. Hier kannst Du mit Deinen Fähigkeiten, Deinen Ambitionen und Deiner Leidenschaft die Zukunft des Gesundheitswesens mitgestalten.
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About the job
Our Team:
You 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.
We look forward to your application!
Main responsibilities:
Ensure regulatory compliance by assessing whether manufacturing and control procedures on site are in line with dossiers approved by Health Authorities
Assessment of and decision on regulatory impact of product-related changes
Manage regulatory site activities for changes with regulatory impact by organization of site meetings and participation in global meetings
Support QA functions for implementation of changes by cross-functional communication of regulatory timelines and approval statuses worldwide
Provides regulatory expertise to site projects like the introduction of new products, process technologies and continuous improvement projects
Support change management of transfer projects by providing regulatory expertise for available product dossiers
Write CMC regulatory documents/dossiers ready for submission by transforming scientific content to consistent CMC language and optimized terminology to facilitate the management of future changes
Support 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 registrations
Prepare with contribution of site experts answers to questions from Health Authorities
Act as interface to Global or Affiliate Regulatory Affairs for QA or Manufacturing functions of the site
Collaborate in creation and maintenance of standard operation procedures with regulatory context
Contribute to and support continuous improvement of performance and efficiency of regulatory working processes
Support preparation of inspections and audits and participate as subject matter expert in audits/inspections
Apply and optimize the use of appropriate company software tools to manage all regulatory activities
About you
Experience & Education
Technical pharmaceutical CMC experience (laboratory, manufacturing, analytical control etc.) is desirable
Several years of direct Regulatory CMC experience is preferred
Knowledge of global regulations/guidelines and key Health Authority and Industry trends of advantage
Ph.D or Master in a science/health field (e.g. Chemistry, Pharmacy, Pharmacology, Biology, Biotechnology etc.) or equivalent (not mandatory)
Soft 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 environment.
Technical skills
Knowledge of both Chemical and Biological products is a plus
Skills for handling of internal data management systems and documentation tools
Languages
Fluency (oral and written) in German and English language is required
Why choose us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Benefit from a well-thought-out benefits package that rewards your contribution and commitment.
We take care of you and your family with a wide range of health and social such as high-quality healthcare, numerous prevention programs and coverage for long-term illness. Our 14-week paid family leave for both parents is outstanding as well as a wide range of childcare benefits.
Pursue Progress. Discover Extraordinary.
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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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Mehr Informationen über diesen Standort
Warum bei uns arbeiten?
- Wir stellen nicht nur Medikamente her – wir bewirken etwas. Unser globales Netzwerk modernster Produktionsstätten sorgt dafür, dass Patient*innen die Behandlungen erhalten, die sie brauchen – genau zur richtigen Zeit.
- Innovation treibt uns an. Von KI-gestützter Fertigung bis hin zu weltweit führenden Produktionsmethoden setzen wir neue Maßstäbe in Effizienz und Leistung.
- Hier wachsen Karrieren. Ob in der Produktion, Qualitätssicherung, Ingenieurtechnik oder in der Supply Chain– arbeitest Du mit erstklassigen Talenten zusammen, entwickelst Deine Fähigkeiten weiter und gestaltest die Zukunft der Pharmaindustrie mit.
- Wir tun, was richtig ist. Sicherheit, Nachhaltigkeit, Vielfalt, Gleichberechtigung und Inklusion stehen im Mittelpunkt unseres Handelns – für ein Arbeitsumfeld, in dem alle erfolgreich sein können.
All-In für Vielfalt
Bei Sanofi führen unterschiedliche Perspektiven zu den besten Lösungen für Patient*innen. Erfahre von Monique Vessey, unserer Leiterin der Supply Chain -Transformation, wie ihre persönliche Geschichte ihre Arbeit bei der Bereitstellung lebenswichtiger Medikamente prägt.
"Manufacturing & Supply bildet die Brücke zwischen der Wissenschaft in unseren Forschungslaboren und den Menschen und Gemeinschaften, die wir versorgen."
Brendan O’Callaghan
Executive Vice President of Manufacturing and Supply
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