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Ofertas AMIFE

 Ofertas de AMIFE

22-02-2018 | Regulatory Affairs - CMC Expert

We are looking for a  Regulatory Affairs Officer CMC   with experience within pharmaceutical industry to join our team of Madrid & Barcelona, someone who loves to take new challenges, to work in an international environment and who wants to grow with us.

Regulatory Affairs Officer main responsibilities:

  • Overall management of Regulatory Activities in different regions and procedures worldwide (EU, US, RoW):
    • New registrations
    • Life-cycle management
    • Support in CMC / quality
    • Regulatory strategy and assessment in development
    • Authoring of regulatory documentation
    • Critical revision of regulatory documentation
  • Responsible person for specific client
  • Responsible person for communication with authorities
  • Responsible for achieving deadlines and overall quality of the work to ensure the best client satisfaction
  • Preparation of team-related trainings both internal and external
  • Support in business development and marketing activities
  • Establish processes and work instructions

According to the project the applicable activities can be done for medicinal products, medical devices, cosmetics, biocides, and other regulated products

Empresa: Asphalion, SL
Persona de Contacto: Ester Caravca - HR Ofertas AMIFE
Ciudad: Barcelona y Madrid
Código postal: