Job Summary

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.
• Assist in aligning local regulatory requirements with Amgen’s corporate standards.
• Provide national/regional (as applicable) input to and execute regulatory strategies.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Act as the point of contact with regulatory agencies.
• Plan and manage clinical trial applications through CRO and liaise/coordinate CTA response to queries between CRO and Amgen.
• Manage CRO work invoice and participate in global network.
• Work as a point of contact and oversight for Global Regulatory Affairs & Strategy (GRAAS) between the in-country Functional Service Provider (FSP) and Amgen, ensuring that the FSP delivers per contract as well as the timelines and quality of all regulatory and safety filings.

Key Activities

STRATEGIC AND EXECUTION
• Contributes for the filing plan (MA and Lifecycle maintenance), advising and discussing with the local cross-functional team.
• With general supervision, executes the filing plan (MA and Lifecycle maintenance) for their country(ies), where applicable.
• Ensures regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
• Creates, reviews and approves source text for country labeling, and owns the country artwork based on source text.
• Collaborates with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).
• Reviews and approves the promotional and non-promotional materials.
• Monitors changes in the national legislation and forwards information to local/regional groups communicating the impact to Amgen.
• Monitors the external regulatory environment to help inform/advise in the regulatory decision making.
• Ensures/supports regulatory product compliance (e.g. RIM, PMCs, pediatric and other agency commitments, Renewal).

HEALTH AUTHORITY INTERACTIONS
• Acts as the point of contact with regulatory agencies in fulfilling local obligations.
• Participates/contributes to local agency interactions and their preparation.

COMMUNICATION AND COLLABORATION
• Works closely with cross-functional colleagues in the Affiliate or Hub to align on strategy and deliver Affiliate/Hub goals.
• Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.
• Partners with International Regulatory Leads (IRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.
• Partners with peers to ensure consistency on procedures.
• Acts as contact and create relationships with Agency staff on specific product assignment (if applicable).

COUNTRY SPECIFIC ACTIVITIES
• Assists locally in Healthcare Compliance activities where applicable.
• Participates in local regulatory process improvements, initiatives and training.
• Oversees external vendor/contractor relationships where applicable.

Knowledge and Skills

Experience and Language(Required)

At lease 5 years of directly related experience

Business-level proficiency in Korean and English is required

Scientific and Technical
• 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.
HA Interaction • Under general supervision interact with local health and regulatory authorities for routine matters
Others
• Demonstrate ability to work in teams.
• Ability to understand and communicate scientific/clinical information.

Education & Experience (Preferred)

• Degree and in-depth regulatory experience and/or related to the country(ies).

• 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.Depth knowledge of regional country(ies) legislation and regulations relating to medicinal products.