Regulatory Affairs Associate
A large pharmaceutical organisation is currently expanding and are looking for a Regulatory Affairs Associate to join their team in Italy. This organisation is dedicated to the growth and development of their staff as they are their company.
- Management of activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee(IEC) and any other central authorities for the assigned country/ countries.
- Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate.
- Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS),eTMF and other applicable PRA systems.
- Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the LRAA is responsible for.
- Perform role of Local Reviewer in the QC process as appropriate.
Skills and Requirements
- An undergraduate degree ideally in science, or health-related field.
- Expert knowledge of current regional guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
- Knowledge of Italian MOH portal preferable.
- Fluency in written and spoken English and Italian.
- Your health, your family, your career, your money - the things that matter to you, matter to us.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.