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2 дня назад - 04.03.2021

Regulatory Data Base Specialist

Acino

Адрес: Киев, Берестейская

Main responsibilities:

 

  • Monitoring of legislation related to CTD, eCTD, xEVMPD, IDMP, eSubmissions, and new trends related to DMS, publishing, and databases;
  • Evaluation of the regulatory environment and contribution to providing internal advice and regulatory information within the respective area to ensure data compliance;
  • Execution of data administration in regulatory databases including data entry within RegOps responsibilities, user requests solving, data quality controls and RA reporting;
  • Execution of dossier compilation, electronic publishing into any required format, and technical validation;
  • Execution of user support, providing the expert information and opinions, creation and update of user guides and training materials;
  • Identification of gaps in RegOps processes and work with line manager to implement the necessary new processes (SOPs, WIs) and perform processes revision;

 

Requirements to candidate: 

  • One to three years of regulatory experience in relevant discipline;
  • Good knowledge of regulatory requirements, process, procedures & pathways;
  • Experience in registration of pharmaceutical worldwide. Experience from EU region or eCTD countries gives an advantage;
  • Knowledge of clinical development, pharmacovigilance and products life cycle management;
  • Experience in working in project teams or leading projects.
  • Fluent in both written and spoken English

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