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.

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