Our Team:
You are keen on learning just everything about the manufacturing, packaging, testing and supply of drug device combination 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.
Main responsibilities:
Ensure regulatory compliance for drug device combination products 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
Experience: Device experience (Design Control Principles, MDR, ISO 11608, ISO 13485 etc.) and/or 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 advantage.
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.
Education: Ph.D or Master in a science/health field (e.g. Chemistry, Pharmacy, Pharmacology, Biology, Biotechnology etc.) or equivalent (not mandatory).
Languages: Fluency (oral and written) in German and English language is strongly recommended.
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.
Start 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.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and 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, gender identity, protected veteran status or other characteristics protected by law. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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!