18 mar
ReiThera srl
Roma Provincia

18 mar

ReiThera srl

Roma Provincia

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


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

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