Regulatory Affairs Specialist / sede di Verona

Per potenziamento dell’organico Regolatorio della sede di Verona quadro di potenziamento della propria Quality Unit, si seleziona un/a addetto al regulatory affairs con le seguenti competenze:

  • Writing and updating of EU-CTD (module 3.S);
  • Writing and updating of US DMT type II;
  • Writing and updating of J-DMF;
  • Writing and updating of documentation to obtain or maintain CoS (CEP) at EDQM;
  • Customer technical support;
  • Submission of regulatory documentation worldwide;
  • Regulatory management of changes.

Key skill required:

  • Strong multitasking skills, able to manage different project at the same time;
  • Ability or motivation to be in contact with Worldwide customers for regulatory technical support;
  • Fluent in English (knowledge of Portuguese is a Plus);
  • Dynamic, proactive and willing-to-do person;
  • Bachelor Degree in scientific environment;
  • 3 Years Experience as Regulatory Affairs (in API Production companies or Pharmaceutical groups) or as Quality Assurance;   MOD CMC
  • Available to relocate in Verona