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Sr Associate Regulatory Affairs

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Amgen

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Location:
South Korea , Seoul

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Category:
-

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

The Local Regulatory Representative (Sr. Associate) is assigned to one or more Amgen products. The product(s) assigned have medium complexity programs/strategies and medium impact to Amgen.

Job Responsibility:

  • Assist in aligning local regulatory requirements with Amgen’s corporate standards
  • Provide national/regional input to and execute regulatory strategies
  • Plan and manage local regulatory submissions
  • Ensure local labels are developed and maintained
  • Act as the point of contact with regulatory agencies
  • Plan and manage clinical trial applications through CRO
  • Manage CRO work invoice and participate in global network
  • Work as a point of contact and oversight for Global Regulatory Affairs & Strategy
  • Contributes for the filing plan
  • Executes the filing plan
  • Ensures regulatory submissions are made on time
  • Creates, reviews and approves source text for country labeling
  • Collaborates with Regional and Global Study Operations teams
  • Reviews and approves the promotional and non-promotional materials
  • Monitors changes in the national legislation
  • Monitors the external regulatory environment
  • Ensures/supports regulatory product compliance
  • Acts as the point of contact with regulatory agencies
  • Participates/contributes to local agency interactions
  • Works closely with cross-functional colleagues
  • Exchanges regulatory information and intelligence with other regulatory colleagues
  • Partners with International Regulatory Leads
  • Partners with peers to ensure consistency on procedures
  • Acts as contact and create relationships with Agency staff
  • Assists locally in Healthcare Compliance activities
  • Participates in local regulatory process improvements, initiatives and training
  • Oversees external vendor/contractor relationships

Requirements:

  • At least 5 years of directly related experience
  • Business-level proficiency in Korean and English is required
  • Knowledge of Regulatory principles
  • Working with policies, procedures and SOP’s
  • Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
  • Understanding of drug development
  • Under general supervision interact with local health and regulatory authorities for routine matters
  • Demonstrate ability to work in teams
  • Ability to understand and communicate scientific/clinical information

Nice to have:

  • Depth knowledge of country(ies) legislation and regulations relating to medicinal products
  • Experience in plan/submit/approval of New drug application
  • Experience in clinical trial application and negotiation with MFDS

Additional Information:

Job Posted:
March 01, 2026

Work Type:
Hybrid work
Job Link Share:

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