Regulatory Affairs (Pharmacist)ID:74432
40,000 THB ~ 70,000 THBキングカエオ - スワンナプーム King Kaew- Suvarnabhumi1日 前概要
給与
40,000 THB ~ 70,000 THB
業界
Manufacturing(Chemicals/Materials)
仕事内容
[Product]: Chemical and Medical Device
Responsibilities:
- Preparing registration dossiers according to local regulations and FDA requirements.
- Providing support in relation to permits, licenses, approvals and all registrations, including FDA, BOI, OAE and DIW and applying and reviewing the relevant permits/licenses as required by law/regulations.
- Managing Thai FDA comments during the submission process and ensuring that products will obtain registration approval within related timelines.
- Filing documents for variation amendments.
- Ensuring that all key products will be submitted following the strategic plan.
- Liaising with the regulatory authorities to obtain registration certificate approval or amendment approval.
- Ensuring that products comply with the current laws and regulations.
- Providing support in terms of product importation by ensuring that all documents are aligned with local requirements.
- Arranging and updating packaging artwork of registered products.
求めている人材
応募条件
【Must】
- Bachelor's Degree in Pharmacist
- Hold a Pharmacy License
- Good command of English (able to communicate)
- Happy to work with the documentation tasks
- Have a license and own car
【Advantage】
- Experience in FDA application
- Experience in coordinate with FDA about the medical devices import
- Experience in coordinating with government offices英語
Level 4 - Conversational Level
その他言語
English
その他
福利厚生
- Travel allowance (actual claim)
- Provident fund
- Social security
- Life & Accident Insurance / Health Insurance
- Bonus就業時間
08:30 ~ 17:30
休日
- Sat, Sun
- National holiday職種
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