Teva Pharmaceutical Industries Ltd in Malta is looking to recruit a Regulatory Affairs Associate on a full-time basis.
This position reports to the Sr Mgr Regulatory Affairs and forms part of the Regulatory Affairs Team, supporting the manufacturing site. This position is mainly responsible for supporting the company to obtain and maintain marketing authorisations for EU and Growth Markets, by actively participating in the change control system, by providing regulatory expertise and support in order to avoid any production disruption while maintaining compliance.
The main activities include but are not limited to keeping the dossiers (Module 3 and QoS) fully up to date in compliance with latest regulatory requirements, preparing the necessary documents in support of dossier and variations submissions and responding to queries from Competent Authorities during Marketing Authorisation or Variation procedures.
The position calls for a person having:
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