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.
