Jason Lin
Summary for Jason’s core skill *Regulatory Affairs (RA): (Experience:2013-current) Clinical trial: Phase I & III study submission NPD: Oncology NCE (Tablet),... | Taiwan, Taiwan, Taiwan
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Jason Lin’s Emails ja****@ba****.com
Jason Lin’s Phone Numbers No phone number available.
Social Media
Jason Lin’s Location Taiwan, Taiwan, Taiwan
Jason Lin’s Expertise Summary for Jason’s core skill *Regulatory Affairs (RA): (Experience:2013-current) Clinical trial: Phase I & III study submission NPD: Oncology NCE (Tablet), OTC new drug submission. (Tablet / Spray dosage) PMF: Japan / Italy / Germany / Indonesia; Dosage form: solid/semi-solid, sterile eye solution, shared manufacturing line with MD, Food, Cosmetics, veterinary medicine. Product life cycle Variation: including but not limited to renewal/ labeling information change/site transfer. Any other communication with the health authority. *Pharmacovigilance (PV): (Experience:2015-2023) Taiwan FDA inspection ADR/PSUR reporting for post-marketing products. Drug safety information monitoring and internal PV training. Execution for RMP. Coordinate with Headquarter/KOL/HA for important drug safety issues and prepare for the advisory board. Involve in Clinical trial: ADR reporting flow monitoring. Quality Assurance (QA): (Experience 2017-2020) Product batch release and investigation for product quality issue. SOP development and internal training. GDP registration and renewal. Audit for drug distributor, custom clearance, and troll-manufacturing site as an observer.
Jason Lin’s Current Industry Organon
Jason
Lin’s Prior Industry
Kaohsiung Medical University
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Taipei City Hospital
|
Dermatology Clinic
|
Dapha Trading
|
Daiichi Sankyo Taiwan
|
拜耳
|
Organon
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Work Experience
Organon
Ra/Pv Project Manager (Regional Support To:Hk, Th, Au)
Sat May 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
拜耳
Assistant Regulatory Affairs Manager(Quality Assurance)
Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Dec 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Daiichi Sankyo Taiwan
Regulatory Affairs & Drug Safety Supervior
Mon Jun 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Dapha Trading
New Product And Regulatory Affairs Dept.
Mon Jul 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Dermatology Clinic
Pharmacist
Thu Sep 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Taipei City Hospital
Pharmacist
Thu Apr 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)
Kaohsiung Medical University
Graduate Student
Thu Sep 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Feb 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Jason Lin Email Addresses
FAQ About Jason Lin
-
Jason Lin is located at
Taiwan, Taiwan, Taiwan -
Jason Lin is a
Summary for Jason’s core skill *Regulatory Affairs (RA): (Experience:2013-current) Clinical trial: Phase I & III study submission NPD: Oncology NCE (Tablet), OTC new drug submission. (Tablet / Spray dosage) PMF: Japan / Italy / Germany / Indonesia; Dosage form: solid/semi-solid, sterile eye solution, shared manufacturing line with MD, Food, Cosmetics, veterinary medicine. Product life cycle Variation: including but not limited to renewal/ labeling information change/site transfer. Any other communication with the health authority. *Pharmacovigilance (PV): (Experience:2015-2023) Taiwan FDA inspection ADR/PSUR reporting for post-marketing products. Drug safety information monitoring and internal PV training. Execution for RMP. Coordinate with Headquarter/KOL/HA for important drug safety issues and prepare for the advisory board. Involve in Clinical trial: ADR reporting flow monitoring. Quality Assurance (QA): (Experience 2017-2020) Product batch release and investigation for product quality issue. SOP development and internal training. GDP registration and renewal. Audit for drug distributor, custom clearance, and troll-manufacturing site as an observer. Organon -
Jason Lin currently works in the
Organon -
Jason Lin specializes in
Summary for Jason’s core skill *Regulatory Affairs (RA): (Experience:2013-current) Clinical trial: Phase I & III study submission NPD: Oncology NCE (Tablet), OTC new drug submission. (Tablet / Spray dosage) PMF: Japan / Italy / Germany / Indonesia; Dosage form: solid/semi-solid, sterile eye solution, shared manufacturing line with MD, Food, Cosmetics, veterinary medicine. Product life cycle Variation: including but not limited to renewal/ labeling information change/site transfer. Any other communication with the health authority. *Pharmacovigilance (PV): (Experience:2015-2023) Taiwan FDA inspection ADR/PSUR reporting for post-marketing products. Drug safety information monitoring and internal PV training. Execution for RMP. Coordinate with Headquarter/KOL/HA for important drug safety issues and prepare for the advisory board. Involve in Clinical trial: ADR reporting flow monitoring. Quality Assurance (QA): (Experience 2017-2020) Product batch release and investigation for product quality issue. SOP development and internal training. GDP registration and renewal. Audit for drug distributor, custom clearance, and troll-manufacturing site as an observer. -
Jason Lin speaks the following languages:
No languages available. -
Jason Lin has prior experience in the following industries:
拜耳 , Daiichi Sankyo Taiwan , Dapha Trading , Dermatology Clinic , Taipei City Hospital , Kaohsiung Medical University -
Jason Lin has the following professional experience:
Organon , 拜耳 , Daiichi Sankyo Taiwan , Dapha Trading , Dermatology Clinic , Taipei City Hospital , Kaohsiung Medical University . -
You can view Jason Lin’s
LinkedIn profile at LinkedIn URL. -
Jason Lin’s work email addresses are
[email protected] . -
Jason Lin works at
Organon
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