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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