Manager, Regulatory Affairs

**Job Summary**
Clinical trial activities are growing rapidly and dynamically, and we are currently seeking a full-time, Clinical Trials Regulatory Submissions Manager to join our Local Regulatory in Amgen Korea. This position plays a key role in the clinical trial application management, import licenses and regulatory agency inspections at Amgen.
The Clinical Trials Regulatory Submission Manager is responsible for the overall submission strategy definition including interactions with Health Authority, compiling submission dossier, execution and management of all regulatory activities for clinical trial projects and programs, according to local regulations and Amgen’s policy.
This position interacts directly with International Regulatory Team, CMC Global Product Leads, Clinical Project Management (Local Trial Managers) etc. and collaborates with Regional and Global Study Operations (GSO) teams, Pharmacovigilance, Clinical Supply Chain, Global Study Operations and Functional Se...