Regulatory Affairs Specialist / Verona site

To expand the Regulatory department staff of the Verona site and strengthen its Quality Unit, we are looking for a regulatory affairs employee with the following skills:

  • 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’s 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 to Verona