Amgen Regulatory Affairs Mgr in Seoul, United States
Plan, manage, coordinate and execute regulatory submissions for products within the Amgen portfolio according to the filing plan in compliance with corporate standards, and local regulatory requirements.
Ensure coordination, execution and implementation of Regulatory Affairs processes and deliverables.
Review, evaluate and authorize changes controls related to texts for packaging components
Keep updated the registration file according to local regulations during the product life-cycle
Coordinate and maintain local regulatory, marketing and clinical trial authorizations.
Act as a contact with national regulatory agencies in fulfilling local marketing authorization obligations.
Evaluate the impact of new regulation on the internal process and coordinate the implementation of regulatory changes
Assist in the management of the local regulatory function.
Bachelor's or Master's degree in pharmacy or life science
Minimum 8 years of experience in regulatory affairs (preferably in multinational pharmaceutical industry)
Strong oral and written communication skills
Good command of English