Regulatory Affairs Manager (m/f/d) 897392 - VDF

Baden-Württemberg (DE)
26 Apr 2021
26 May 2021
Full Time
Contract Type
Experience Level

We are currently looking for a  Regulatory Affairs Manager for a permanent position based in Nördliches Baden-Württemberg. As a Regulatory Affairs Manager, you will be responsible for the management of a varied product-portfolio in all capacities relevant to governmental approval regarding quality, efficacy and safety, through close cooperation within the company and with external partners.

Main Responsibilities:

  • Preparing and performing national and international marketing authorisation applications
  • Lifecycle management of approved products such as variations and renewal procedures
  • Content related and formal handling of registration dossiers in eCTD format
  • Interdepartmental cooperation in the establishment of new CMOs

Qualifications and Experience:

  • Degree in pharmacy, another natural science or comparable education
  • Several years of experience in the field of regulatory affairs in the EU is required, experience in countries outside the EU is beneficial
  • Excellent communication skills in English
  • Good knowledge of German or the willingness to learn the German language, knowledge of additional languages is an advantage
  • A perceptive, pragmatic and solution-oriented way of thinking
  • Independent and results-driven working style
  • Ready for action and dependable personality

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