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Regulatory Affairs Associate - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
  • Miejscowośćinne
  • AdresItaly,
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Regulatory Affairs Associate

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  • Regulatory Affairs Associate (f/m) Rome

    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.

    Your Tasks

    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

    Your profile

    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)

    To apply

    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


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