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: 

• 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