Regulatory Affair
Able Medical Co., Ltd. (Bang Khen, Bangkok)
Bangkok,
Thailand
At ABLE MEDICAL, we take immense pride in being a leading sterile injectable manufacturer in Thailand. With a strong commitment to pharmaceutical excellence, we have established ourselves as a key player in the industry, offering a wide range of high-quality pharmaceutical products. Our state-of-the-art facilities and dedicated team of experts enable us to meet the growing demands of the healthcare sector.
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Job function:
Legal & Compliance
About this position
The Regulatory Affair position involves preparing product dossiers, coordinating regulatory submissions, and ensuring compliance with regulations.
Responsibilities
• Prepare product dossier in ACTD format
• Assisting in coordinating and tracking of regulatory submissions
• Maintain regulatory compliance.
• Update stakeholders of relevant changes in regulations and prepare action plans to comply with the regulations.
Requirements
• Undergraduate degree in Bachelor of Science
• 3-5 years of experience in preparing dossier in ACTD format
• Experience in dealing with ASEAN authorities is a plus
• Good English reading and writing
• Team player with good interpersonal skills
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