Regulatory Affairs & Pharmacovigilance Manager, ASKAN

THE POSITION This position is responsible for managing the end-to-end product registration process, ensuring compliance with local regulatory authorities and Global Regulatory Affairs (GRA), maintaining product licenses, and supporting life cycle management (LCM) activities. It also oversees the Regional Operating Unit (ROPU) Pharmacovigilance (PV) system in alignment with local regulations and global PV requirements. The role serves as a key link between GRA and Regulatory Affairs (RA) functions across ROPU ASKAN countries, providing support in the execution and coordination of RA activities within the region. In addition, the position acts as Deputy Local Pharmacovigilance Officer (Deputy LPVO), supporting pharmacovigilance reporting and ensuring effective coordination between Global PV and ROPU ASKAN countries in compliance with both local and global standards. In close collaboration with the LPVO, the role serves as a primary point of contact for country RA managers across ROPU ASK...