Ця вакансія вже завершена
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.