Career Category

Regulatory

Job Description

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.

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