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Regulatory Affairs Specialist
vor 2 Wochen
On behalf of our business partner, we are currently looking for a qualified Regulatory Affairs Associate . Use our service as a springboard into an attractive company in the pharmaceutical industry in Berlin . Apply directly online now - or contact us by phone or e-mail and let our friendly colleagues advise you without obligation. By the way: We value equal opportunities and welcome applications from people with disabilities, whose inclusion is of particular concern to us.
Here's what we offer
Attractive salary package with Christmas and vacation bonuses Up to 30 days vacation per year Skills development through a variety of e.learnings Special conditions when purchasing concert tickets, electronic devices, sports equipment and much more Regular team events such as summer parties and Christmas parties
Your tasks
Planning, organization and implementation of national procedures for new marketing authorizations, marketing authorization renewals and marketing authorization variations for medicinal products Collaboration on corresponding European procedures (MRP, DCP, CP) for medicinal products in close cooperation with the European authorization team Implementation of regulatory and safety-related requirements in the product texts of medicinal products Regulatory assessment of projects to obtain and amend marketing authorizations Acting as an interface to national authorities and employees in the Marketing, CMC, PV and Quality departments
Your profile
Degree in natural sciences (e.g. chemistry, biology), possibly also pharmacy or medicine Degree as Master of Drug Regulatory Affairs desirable Several years of professional experience in regulatory affairs in the pharmaceutical industry Good knowledge of relevant legislation for medicinal products Confident handling of electronic submissions and internet-based systems Good written and spoken German and English skills Analytical skills, a high degree of process thinking as well as strong communication and interpersonal skills Good organizational and teamwork skills as well as a reliable, independent, structured and precise way of working-
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