Jiwon Shin
Summary
Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.
Overview
4
4
years of professional experience
9
9
years of post-secondary education
Work History
Sr. Regulatory Affairs Specialist
Synex Consulting Ltd.
Soeul
8 2021 - Current
- Established strong rapport with external stakeholders such as global pharmaceutical companies, regulatory agencies, and CRO for efficient communication and compliance.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Prepared and submitted regulatory file applications and supporting documentation.
07.2024 - Current
- Currently in the process of preparing application of IND (Phase 1)
- Scope: Preparation of documents for application (manufacturing methods, DP specification and testing methods, in-house specification, etc.) (in progress), application cover (scheduled), compilation of data (scheduled)
06.2024 - Current
- Currently in the process of preparing documents for application (manufacturing methods, DP specification and testing methods, in-house specification)
12.2023 - Current
- Currently in the process of preparing application of drug approval
- Scope: Preparation of documents for application (manufacturing methods, DP specification and testing methods, in-house specification, etc.), application forms, compilation of data
11.2022 - Current
- Completed orphan drug designation process
- Currently in the process of obtaining drug approval (under review after official submission for 1st supplementary request)
- Scope: Preparation of documents for application (manufacturing methods, DP specification and testing methods, in-house specification, etc.), application forms, compilation and submission of data, preparation and submission of supplementary data, Client (Headquarters) & HA Communication
- Responsible for the comprehensive management of SE, CMC, GMP
12.2021 - Current
- Successfully completed 5 drug approvals and 46 variation approvals with 9 currently in progress
- Currently in the review process of drug approval for 1 new variant
- Completed 11 pre-reviews and preformed 2 EUA and 1 EUA variation
- Conducted 6 overseas manufacturer registrations, 1 transfer of ownership, 2 import business reporting, and 2 contract manufacturing and sales reporting
- Issued 11 English certificates and notarized documents
- Scope: Preparation of documents for application (manufacturing methods, DP specification and testing methods, in-house specification, etc.), application forms, compilation and submission of data, preparation and submission of supplementary data, Client (Korea Branch) & HA Communication
- Responsible for the comprehensive management of SE, CMC, GMP
- Revenue and Client Retention: Consistently exceeded departmental sales targets over two consecutive years and secured successful contract renewals with the client.
11.2021 - Current
- Performed 8 DMF registration
- Performed 8 DMF variation registration with currently 1 in progress
- Completed 3 DS-DP linked review
- Performed 5 overseas manufacturer registration and 3 annual reports
- Currently managing a license transfer project for one product
- Scope: Compilation and submission of registration data, preparation of application forms, and Client (Headquarters) & HA communication
Regulatory Start-Up - SSU (Internship)
IQVIA
02.2021 - 05.2021
- Performed IRB Submission for 2 projects
- Performed budget negotiation
- Prepared and submitted supplementary data and performed Client (Headquarters) & HA communication for to obtain drug approval
- Responsible for the comprehensive management of SE, CMC, GMP
- Wrote classification report for a specific product as medical devices/drugs and OTC/ETC: Authored 1 report
- Conducted regulation change monitoring and searched for articles related to the pharmaceutical industry
- Presented regulation updates during company-wide meetings: 4 times
- Conducted 1 regulation study and internal training session
Education
Master of Science in Pharmacy - Industrial Pharmaceutical Science
Yonsei University
Seoul, Korea 08.2019 - 08.2021
Bachelor of Science - Biotechnology
Konkuk University
Seoul, Korea 03.2012 - 08.2019
Skills
Proficient in Microsoft Word and Excel, Basic knowledge of SAS
Teamwork and Collaboration
Customer Service
Problem-Solving
Microsoft Office
Time Management
Multitasking
Calm Under Pressure
Excellent Communication
Languagefluency
Proficient in English writing and reading, Intermediate in English speaking
Experiencedwith
Veeva
Research
- A study on the establishment of an adverse events management system for Korea through the collection, analysis, and evaluation system investigation of adverse events caused by the off-label use of drugs in foreign countries, MFDS, 05/2019, 11/2020
- Efficacy of first-line and second-line treatment with biologics in Crohn's disease: network meta-analysis, Yonsei University, 10/2020, 07/2021
Training
- GCP Basic course (KONECT), 06/2021
- Education for training experts in pharmaceutical regulatory science (KFDC), 06/2020, 08/2020
Timeline
07.2024 - Current
06.2024 - Current
12.2023 - Current
11.2022 - Current
12.2021 - Current
11.2021 - Current
Regulatory Start-Up - SSU (Internship)
IQVIA
02.2021 - 05.2021
Master of Science in Pharmacy - Industrial Pharmaceutical Science
Yonsei University
08.2019 - 08.2021
Bachelor of Science - Biotechnology
Konkuk University
03.2012 - 08.2019
Sr. Regulatory Affairs Specialist
Synex Consulting Ltd.
8 2021 - Current
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