Regulatory Affairs Manager

Regulatory Affairs Manager

BioNTech

Mainz, Germany

Here, you’ll achieve greatness

At BioNTech, you will play a central role at the interface between manufacturing, non-clinical, clinic, medical device - entering new ground in the field of regulatory requirements for individualized immunotherapies. Your duties in detail:

  • Support in conduct of interactions with national authorities and international agencies (e.g. MPA, PEI, EMA, FDA and WHO) in the scope of product development and market authorisation
  • Support in performance of regulatory activties in preparation of market authorisation incl. compiling of MAA/BLA dossier in the areas Europe and US
  • Regulatory Intelligence: Monitoring changes and evolution of regulatory landscape for both drug and medical devices. Analyzing the impact of drug/devices changing regulations for BioNTech's products

What you have to offer

  • Degree in natural sciences or regulatory affairs or comparable studies
  • Experience in the field of regulatory affairs (US area preferred) is advantageous
  • Experience in the field of biologics in clinical development is desirable
  • Very good knowledge of the relevant laws and guidelines
  • Very good English skills are a must, German skills are a plus

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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