SynteractHCR is an international CRO located in EU, RUS, US and South America. As we are growing we are looking for a dedicated Regulatory Affairs Associate to join our Team in Italy. We offer you a challenging and rewarding job opportunity in a fast moving, flexible environment and a highly motivated team.
Submission and coordination of regulatory applications of clinical trials to authorities and ethics committees (e.g. clinical trial application, end of trial notification and report submission) Compilation, review and assessment of all documents required for clinical trials, e.g. study protocol, patient information and product labelling Support Regulatory Affairs Manager by preparing core dossiers Ensure that applications are conducted according to local and international requirements/procedures (ICH-GCP, applicable local law and guidelines, applicable SOPs) Assist with query reply to authorities and ethics committees Attend project team meetings Prepare regulatory documents for translation Assistance with regulatory intelligence by monitoring the local and global regulatory environment and providing regulatory summaries Collaboration with Clinical Operations, Safety and other internal departments
Bachelor's degree in life sciences, business or a related field of study Regulatory Affairs experience in a company dealing with clinical trials Strong understanding and knowledge of local requirements of Ethics Committees and Competent Authorities submission procedures on clinical trials according to international and national laws and guidelines Proficiency in MS Office and regulatory databases Effective verbal and writing skills (Italian / English)
Have we sparked your interest? Then we are looking forward to receiving your application! Please apply through our homepage synteracthcr.com and state your earliest start date/notice period and your desired salary. If you have any questions regarding the position please contact antonia.schultzeynteracthcr.com