Kasidech Boonsermsukcharoen
Regulatory Affairs Associate at Daewoong Pharmaceutical (Thailand) Co., Ltd.- Claim this Profile
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Bio
Credentials
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การอบรมระบบการขึ้นทะเบียนตำรับยาแบบ e-Submission
มูลนิธิสำนักงานคณะกรรมการอาหารและยาSep, 2022- Sep, 2024 -
Common Technical Document (CTD) of Generic Drug Registration in the international countries
The International Health Policy Program (Thailand)Apr, 2022- Sep, 2024 -
Pharmacy License
Food and Drug AdministrationMay, 2019- Sep, 2024
Experience
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Daewoong Pharmaceutical (Thailand) Co., Ltd.
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Thailand
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Associate
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May 2022 - Present
- Responsible for chemical drugs and biologics registration (eCTD-submission) - Animal food supplement registration. - Risk classification, grouping, and e-submission of medical devices (IVD and Non-IVD). - GMP clearance and sample importing permission process. - Advertisement submission including application via auto-approval. - Any renewal processes. - Any variations from the current registration. - Annual importing and selling of drug and medical device reports. - Responsible for chemical drugs and biologics registration (eCTD-submission) - Animal food supplement registration. - Risk classification, grouping, and e-submission of medical devices (IVD and Non-IVD). - GMP clearance and sample importing permission process. - Advertisement submission including application via auto-approval. - Any renewal processes. - Any variations from the current registration. - Annual importing and selling of drug and medical device reports.
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Regulatory Affairs Pharmacist
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Jun 2019 - May 2022
• Responsible for preparing drug registration documents as ACTD format submitting to Thai FDA including foreign FDA. • Keep up to date with changes or variation in regulatory legislation and guideline, especially in Thai FDA. • Prepare supporting documents to register some health supplement products. (for foreign country) • Update specification and COA of raw material including finished product for renew or re-registration. (for foreign country) • Responsible for preparing drug registration documents as ACTD format submitting to Thai FDA including foreign FDA. • Keep up to date with changes or variation in regulatory legislation and guideline, especially in Thai FDA. • Prepare supporting documents to register some health supplement products. (for foreign country) • Update specification and COA of raw material including finished product for renew or re-registration. (for foreign country)
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Regulatory Affairs Intern
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Jan 2019 - Mar 2019
• Reviewed drug marketing authrization on basis of quality, safety and efficacy • Drafted drug control-related laws. For example, renewal of drug registration, good clinical practices related regulation, etc. • Reviewed drug marketing authrization on basis of quality, safety and efficacy • Drafted drug control-related laws. For example, renewal of drug registration, good clinical practices related regulation, etc.
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Trainee, Quality assurance, Quality control and Production pharmacist
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Aug 2018 - Dec 2018
• Observed roles of pharmacist including QA, QC and PD. • Presented project assigned from pharmacist. For example, Cleaning validation and computer validation. • Observed roles of pharmacist including QA, QC and PD. • Presented project assigned from pharmacist. For example, Cleaning validation and computer validation.
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Sungkyunkwan University
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South Korea
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Higher Education
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700 & Above Employee
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Research And Development Intern
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May 2018 - Jul 2018
• Respondsible for conducting proposal leading to do a research. • Developed a formulation refer to proposal and evaluated. • Discussed and concluded results • Conducted and summited to internaltional publication. • Respondsible for conducting proposal leading to do a research. • Developed a formulation refer to proposal and evaluated. • Discussed and concluded results • Conducted and summited to internaltional publication.
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Education
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2013 - 2019
Chiang Mai University
Bachelor's degree, Pharmaceutical Sciences
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