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Regulatory Affairs Analyst

OLIC (Thailand) Limited
OLIC (Thailand) Limited (Bang Pa-in)
Ayutthaya, Thailand 🇹🇭
OLIC (Thailand) Limited
OLIC has cultivated successful relationships that last. The company is a trusted partner to over 30 multinational companies, including most of the Big Pharma organizations. The OLIC manufacturing facility complies with GMP requirements following the PIC/S guide to Good Manufacturing Practice for Medicinal Products. Products made by OLIC serve not only the markets in Thailand and Southeast Asia, but also Japan, Australia, the US and Europe.

About this position

The Regulatory Affairs Analyst is responsible for regulatory activities related to drug, cosmetic, food, herbal, and medical device products, ensuring compliance with registration and current practices.

Responsibilities

• Prepare, Submit, coordinate and support for product registration and amendment for drug and herbal product.
• Responsible for product notification of cosmetic, Food & Medical device product and life cycle maintenance.
• Responsible for receive advers event case and submit the case of cosmetic, Food & Medical device product to Thai FDA.
• Supporting other regulatory activities, for example renewal project of the product license.
• Prepare annual report for cosmetic, Food & Medical device product.

Requirements

• Bachelor’s degree of Science in Chemical, or related fields.
• 0-2 years in Regulatory Affairs, Chemical, QC, QA working experience would be advantage.
• Good command of written and spoken English and computer literacy.
• Good Communication and coordinator skill.
• Patient and perseverance to hard work.

Benefits

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Huneety A.I Salary Estimate
120,000 - 300,000 THB per month