Regulatory Affairs Manager
Amgen · Seoul, South Korea
RegulatoryFull-timeCompany career page
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Role summary
Amgen seeks a Regulatory Affairs Manager for its Seoul office to oversee medium-complexity product regulatory strategies, submissions, and agency interactions. The role involves aligning local requirements with corporate standards, managing clinical trial applications, and serving as the primary contact with South Korean regulatory authorities.
What they're looking for
- Master's degree in scientific field plus 3 years regulatory experience, or Bachelor's plus 5 years
- Knowledge of regulatory principles, drug development, and medicinal product legislation
- In-depth familiarity with South Korean regulatory environment and MFDS procedures
- Experience with clinical trial applications and new drug application submissions
- Strong written and oral communication skills in English and Korean preferred
- Negotiation and cross-functional collaboration abilities
What you'll be doing
- Execute filing plans for marketing authorizations and lifecycle maintenance activities
- Develop and maintain country-specific product labels aligned with local legislation
- Serve as primary liaison with South Korean regulatory agencies on assigned products
- Oversee clinical trial applications through contract research organizations
- Review promotional materials and monitor changes in local regulatory requirements
Privacy & handoff
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