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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 !
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