Global Regulatory Affairs Clinical Trials Coordinator - VIE Contract
Sanofi Group
**Global Regulatory Affairs Clinical Trials Coordinator - VIE Contract**
+ _Location: Germany, Berlin_
+ _Target start date: 01/11/2025_
iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.
PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.
**About the job**
_As_ **_Global Regulatory Affairs Clinical Trials Coordinator VIE_** _within our Global Regulatory Affairs team, you’ll manage regulatory activities related to Clinical Trials Applications, from planning and dossier preparation, then submission, responses to Health Authorities and approvals of Trials. We are developing our knowledge in Clinical Trial Applications (CTA) related Intelligence, in particular our knowledge in the European Clinical Trial Regulation. Your work will support knowledge development, and field experience for the European Clinical Trial Regulation processes._
_Ready to get started?_
_Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions._
**About Sanofi**
_We’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 responsibilities:**
+ Provide regulatory expertise to Sanofi key stakeholders and help teams understand and follow important healthcare regulations.
+ Set up processes and coordinate the preparation of Clinical Trial Applications (CTAs).
+ Work closely with different departments including R&D, Clinical Operations, and Pharmacovigilance teams.
+ Ensure all documentation meets quality standards.
+ Monitor the progress of CTAs through submission and approval stages.
+ Identify potential issues early and develop practical solutions, keep projects moving forward on schedule and drive process improvement.
+ Help implement new regulatory processes (eg. Clinical Trial Regulation in Europe, EU Clinical Data Disclosure).
+ Contribute to developing more efficient ways of working, stay current with changing regulations and help teams adapt.
**About you**
**Experience:**
+ Previous experience in pharmaceutical industry in Regulatory Affairs or similar field.
+ Clinical Trial Regulations experience is highly preferred.
**Soft and technical skills:**
+ Good communication & negotiation skills.
+ Proactiveness, and problem-solving ability.
+ Ability to work with cross-functional teams.
+ Ability to handle multiple tasks and projects simultaneously.
**Education:**
+ Master’s Degree in Pharmacy, or other relevant scientific field.
**Languages:**
+ Fluency in English, German knowledge would only be an asset, but is not needed for the job.
**Why choose us?**
+ Be part of a pioneering biopharma company where patient insights shape drug development.
+ Work at the forefront of AI-powered science that accelerates discovery and improves outcomes.
+ Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams.
+ Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
+ Help improve the lives of millions of people globally by making drug development quicker and more effective.
+ Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.
iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.
Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.
\#LI-EUR
**Pursue** **_progress_** **, discover** **_extraordinary_**
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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !
Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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