Regulatory Data base Specialist

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: 

• University graduates or people with one or more years of regulatory experience in relevant discipline;
• Good knowledge of regulatory requirements, process, procedures & pathways gives an advantage;
• Bachelor Degree in Chemistry, Biotechnology or Biomedical sciences (Medicine / Pharmacy / Pharmaceutical Sciences / Science), post-graduate in business or sciences as a plus
• Upper intermediate in both written and spoken English

This position is temporary on the period of mobilized employee.