Assistant (all genders) Regulatory Affairs
Together with the Regulatory Affairs Manager, you will provide our customers with the best possible support in a wide range of authorisation tasks. You will work in an international environment and be involved in the preparation, submission and implementation of worldwide marketing authorisation procedures.
A challenging task
- Support in the preparation and implementation of EU-wide authorisation procedures (MRP/DCP, CP) and variations
- Preparation of authorisation documents
- Support of the Regulatory Affairs Manager regarding the support of our customers in the submission of worldwide authorisation procedures and variations
- Correspondence with customers and authorities
- Entering documents in our eCTD/document management system and maintaining data in the marketing authorisation database
- Filing, archiving, electronic submission
A convincing background
- Completed training as a PTA, medical documentalist or a comparable qualification
- Professional experience in the pharmaceutical industry would be desirable
- Structured way of working, high demands on your own work and the ability not to lose your head or sense of humour even in hectic times
- Analytical thinking skills
- Very good communication skills
- Enjoys new challenges
- Good written and spoken German and English skills
An exciting environment
You will be working in an internationally successful company in the buzzing heart of Hamburg, directly at the Elbe river. We offer you flexible working hours and the opportunity to work on a mobile basis. In addition, you can look forward to a variety of design and training opportunities, language courses, regular team events and a lot of fun besides work. You can expect a varied job in a motivated and friendly team, an uncomplicated interaction with each other and many opportunities to contribute your own ideas. And we have our own canteen with really delicious food. Come and convince yourself!
You are interested in our company and the position we can offer you?
Then we ar e looking forwar to your online-application - Just click on "Apply now!".
