Phuong Hung

I am a careful and responsible professional with experience in Regulatory Affairs and operational support within a Vietnamese pharmaceutical company and a Korean representative office. My experience includes supporting the preparation of regulatory dossiers and product-related legal documentation, reviewing product information and labeling, following up on compliance requirements, supporting administrative and operational activities, coordinating across departments, and communicating with international partners and teams. I am seeking a stable working environment in Ho Chi Minh City where I can apply my experience, continue developing my professional skills through teamwork and collaboration, and make a reliable long-term contribution to the company.

GC BIOPHARMA REPRESENTATIVE OFFICE | Regulatory Affairs & Operations Executive

May/ 2024 – Dec/ 2025

Product Registration & Compliance:

· Coordinated among GC Headquarters in Korea, the Vietnam Representative Office, and the local distributor; followed up on registration progress, dossier/document status, and outstanding requirements.

· Supported document review and registration-related activities for vaccines and biological products, coordinating with GC Headquarters and the RA team.

· Supported the launch of a new vaccine product in Vietnam and coordinated product training activities for the exclusive distributor.

· Reviewed product labeling against applicable Vietnamese requirements and followed up on relevant regulatory and Pharmacovigilance requirements.

Documentation & Translation:

· Translated scientific and regulatory documents (English ↔ Vietnamese); managed and organized regulatory and office documentation to support registration activities and document retrieval.

· Prepared weekly and quarterly work progress reports for GC Headquarters, providing updates on ongoing activities and items requiring further follow-up.

Operational Support

· Coordinated with the distributor to support the successful completion of the first two commercial import shipments to Vietnam in late 2025, including follow-up on documentation, labeling, and shipment packaging requirements.

· Coordinated with relevant departments and local partners on administrative and operational activities to support smooth day-to-day office operations.

SHINE PHARMA CO. LTD. | Administrative & Regulatory Affairs Staff

Sep/ 2017 – Apr/ 2024

Drug Registration & API Sourcing:

· Sourced, collected, and followed up on supporting documentation for an average registration plan of 5 new products/month during 2019–2020; coordinated with RA team members and suppliers to address document revision/additional-information requests.

· Reviewed drug labeling against applicable Vietnamese requirements; translated package inserts, brochures, scientific content, and other registration-related documents.

· Organized registration dossiers and monitored marketing authorization validity, renewal timelines, dossier status, and related requirements.

· Sourced API suppliers and manufacturers internationally; collected quotations and DMFs, followed up on technical review feedback, and identified alternative sources when documentation or legal qualifications did not meet requirements.

· Successfully collected suitable quotations and DMFs for 20+ ETC active pharmaceutical ingredients, supporting the company's generic product portfolio development.

Business & Operations Support

· Supported wholesale price declaration, API import documentation, delivery follow-up, and hospital tender documentation.

· Coordinated among RA, Manufacturing, Tender, Accounting, and Warehouse teams; supported attendance/payroll coordination, office expenses, administrative documentation, and order checking.

Bachelor of Pharmacy | Nguyen Tat Thanh University (2024)

Classification: High Distinction

Bachelor of Arts in English | Sai Gon University (2013)

Classification: Good