Align local regulatory requirements with Amgen corporate standards and strategies
Plan and manage local regulatory submissions per corporate and legal rules
Develop and maintain local labels per legislation and Amgen procedures
What they want
Doctorate or master's in a scientific field plus three years related experience
Or bachelor's in a scientific field plus five years related experience
Knowledge of regulatory principles,policies,procedures,and SOPs
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Nice to have
In-depth regulatory experience related to the assigned country or countries
Deep knowledge of country legislation for medicinal products
Experience planning,submitting,and approving new drug applications
Seoulstart's read
Visa tier (likely)
E-7 specialty / professional (likely)
Korean language
Korean not required
English friendliness
High: JD in English, foreign-friendly signals
Context
Multinational biopharma Seoul affiliate; MFDS negotiation experience is explicitly preferred for this local regulatory representative role.
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.