Amgen

Regulatory Affairs Manager

South Korea - SeoulRecently posted

Apply on Amgen's career page

What you'd do

Plan and manage local regulatory submissions per Amgen and Korean requirements
Serve as the primary point of contact with Korean regulatory agencies (MFDS)
Develop and maintain local product labels in line with local legislation

What they want

Doctorate or master's with 3 years,or bachelor's with 5 years,of related experience
Knowledge of the Korean regulatory environment and national drug legislation
Strong communication,negotiation,and cross-functional collaboration skills

Nice to have

In-depth Korean regulatory experience with new drug applications
Experience negotiating clinical trial applications with MFDS

Seoulstart's read

Visa tier (likely): E-7 specialty / professional (likely)
Korean language: Korean requirement not stated
English friendliness: Medium: English JD, mixed-language workplace
Context: Requires deep knowledge of Korea's MFDS regulatory process and direct agency interaction,so a foreign resident would need existing familiarity with the Korean regulatory system even though no Korean level is explicitly stated.

This is Seoulstart's analysis of the public job description, not the employer's stated policy. Verify visa sponsorship, language requirements, and remote allowances directly with the recruiter.

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