8 days ago on adecco.ch

International RA Manager (m/f)

Adecco Human Resources AG

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 Please refer to JobSuchmaschine in your application

International RA Manager (m/f)

For an international company specializing in the development and manufacturing of
biopharmaceutical products, we are currently looking for an experienced:

International RA Manager (m/f)

Your challenges

As a member of the global Regulatory Affairs group in the German speaking part of Switzerland you are responsible for:

  • Management of regulatory affairs activities related to the development and registration of biopharmaceutical products
  • Preparation of new regulatory dossiers in the international field with focus on FDA and European Authorities
  • Maintenance of dossiers based on changes and advice on the type of changes Answering questions to authorities as well as internal and external partners
  • Definition of regulatory strategies
  • Coordination with internal positions involved in dossier preparation
  • Representation of the RA department in interdisciplinary project teams
  • Management of regulatory projects

Your skills

  • Advanced degree in science (Biology, Biotechnology, Chemistry, Pharmacy or any other relevant discipline)
  • Minimum 3 years' working experience in Regulatory Affairs
  • Broad knowledge of submissions in the EU and/or the USA
  • Previous experience in regulatory affairs for biologics
  • Understanding of eCTD formats / requirements
  • Knowledge of specific regulatory requirements from different regulatory bodies
  • Excellent communication, presentation and organizational skills
  • Process-oriented team player who is able to work in international, multi-cultural and cross-divisional project teams
  • Flexible, open-minded and committed person, capable of working independently
  • Business fluent in English (spoken and written), knowledge of German would be a plus

Your contact

<div class="contact-with-thumbnail"><div class="contact-partner-img"><img src="/Contact%20image%20Library/.jpg"/></div><
Frau Simone Dünneisen, Consultant Retail, looks forward to answer your questions by phone or eMail.

You can apply directly online, or by eMail. Please mention reference 152/SIDU/1984-2 in your application.