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
