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
