Regulatory Affairs Consultant

UNIT: Regulatory Affairs

We are looking for a Regulatory Affairs Consultant to be inserted in the headquarters of Florence/Parma and to be activated as operational support at the Company’s customers in the area of Florence, Parma and Milan. The ideal candidate has a degree in scientific disciplines (Chemistry, Biology, Pharmacy) and an experience in similar role of at least 2 years.

What we will do together

  • Preparation of the necessary scientific documentation for the lifecycle management of national products in compliance with current AIFA regulations: Variations IA, IB, II, renewals and related submission through the AIFA portal;
  • Review and updating of Product Information;
  • eCTD sequence preparation
  • Review and update of registration dossiers, gap analysis and subsequent assessment of regulatory strategy

What we are looking for

  • Excellent knowledge of the English language
  • Availability for frequent domestic and international trips
  • Knowledge of ICH, AIFA, EU guidelines and international regulations and directives
  • Problem solving
  • High communication skills with external and internal customers

What we have in common

Reliability, accordance, respect, care, curiosity, courage, perseverance and passion are the values ​​that represent us. If you have these values in common with us, send your application.

APPLICATION

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