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Global Regulatory Affairs Manager (m/f) - limited for 1 year

Posted 26 Jun 2018

Darmstadt, Hesse - Germany

Req Id 177836

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. 
 


The position manages the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentations in cooperation with external partners. In addition the Global RA Manager will support the Marketed Product Leader in executing regulatory strategies and project managing regulatory submissions in partnership with GRA’s external strategic partner while working closely with the Global Regulatory Marketed Products Operations Management group. This position contributes Member of the Regulatory Subteam and Clinical Trial and will ensure close cooperation with headquarter and country regulatory affairs functions worldwide

 

Who you are:

  • Degree in a Life Science or related discipline, higher degree preferable (e.g. PhD, MSc, MBA)Several years of industry experience with at least 3 years’ regulatory experience
  • Experience in preparation and submission of dossiers including clinical trial applications in at least one ICH region, the preparation of documents for regulatory agency interactions, regulatory maintenance activities for authorizations in a local affiliate or head office and as a member in project teams.
  • Solid knowledge of European regulatory procedures and requirements
  • Experience with regulatory agency interactions and preparation of documentation to support interactions
  • Knowledge of international regulatory affairsFluent in spoken and written English
  • Good interpersonal , team work and project management skills


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

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