Junior Expert Drug Regulatory Affairs (m/w/d)
Are you ready to make a significant impact in the ever-evolving medical technology industry? As a Junior Expert in Drug Regulatory Affairs, you'll play a crucial role in ensuring that cutting-edge medical products meet regulatory standards across global markets. This position offers you the opportunity to collaborate with multiple departments—such as Quality Control, Manufacturing, and Clinical Research—while honing your expertise in regulatory processes, dossier preparation, and compliance. If you're driven by precision, passionate about healthcare innovation, and eager to contribute to global health solutions, this is the perfect role for you.
Your tasks:
- Support and preparation of approval dossiers in accordance with country-specific requirements
- Updating the marketing authorization dossiers
- Support in the processing of deficiency notifications and change notifications worldwide
- Support in Creation, review and approval of product information texts
- Support in the implementation of approval requirements in the Quality Control, Manufacturing, Quality Assurance and Clinical Research departments
Your profile:
- Completed bachelor's degree (e.g. pharmacy, human medicine, natural sciences) or similar
- Some initial professional experience is required to successfully take on the role
- To successfully fulfill this role, a foundation of prior professional experience is essential
- Ability to set and change priorities appropriately or to meet conflicting requirements
- Quality-conscious, systematic and results-oriented way of working
- Good knowledge of English (spoken and written)
Our offer for you:
There is a lot you can discover at Fresenius because we have a lot to offer. No matter what field you are an expert in and how much experience you have - for your professional future with meaning:
- The opportunity to work remotely
- Whether in front of or behind the scenes - you will help to make better medicine accessible to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
- A large number of committed people with a wide range of skills, talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.