Reithera Srl


Regulatory Affairs Expert

We are currently looking for a REGULATORY AFFAIRS EXPERT that will be responsible for providing support to the regulatory strategy for the assigned projects. He/She will focus on: • Interaction with the key decisive Regulatory Agencies • Preparation of documentation and application to Italian and foreign Regulatory Authorities in compliance with current legislations to ensure efficient submission of Phase I Clinical Trials • Maintain TMF related to ongoing studies and all regulatory documentation • Update, review, and maintain electronic databases for clinical trials. Maintaining and processing of local regulatory database • Strict cooperation and synergy with scientific team and manufacturing unit, being part of a cross functional team • Regulatory correspondence with PI's and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates • CRO oversight • Prepare investigator/pharmaceutical company meeting minutes • Analyze preclinical/clinical research data, perform literature searches and extract information to support regulatory documents and prepare reports on findings Requirements: • University degree in life scientific (preferably biological science, biotechnology, pharmacy or pharmaceutical chemistry) • At least 3 year of experience in healthcare companies in regulatory role dealing with medicines or/and medical devices • Good English written and verbal communication skills with the ability to effectively and precisely present data • Attention to details with proven ability to establish priorities & achieve results • Multitasking attitude and problem-solving approach • High quality and ethical standards

Riferimento annuncio: 3699
Data Pubblicazione: 17 settembre 2018
Luogo di svolgimento: Roma [RM] - Lazio
Settore: Produzione e Industria
Tipo di contratto: Tempo determinato

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