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. Ensure regulatory compliance by assessing whether manufacturing and control procedures on site are in line with dossiers approved by Health Authorities
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)
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
Technical pharmaceutical CMC experience (laboratory, manufacturing, analytical control etc.) Knowledge of global regulations/guidelines and key Health Authority and Industry trends of advantage
Chemistry, Pharmacy, Pharmacology, Biology, Biotechnology etc.) Skills for handling of internal data management systems and documentation tools
Fluency (oral and written) in German and English language is required
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
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