Job Description

Our client is a global pharmaceutical company in Thailand.

They're now looking for a Regulatory Affairs to join them.

Responsibilities

• Coordinating closely with suppliers to obtain complete registration documents for faster product registrations in Thailand.  
• Preparing submissions to the local health authority for new products, license renewal, and variations to existing products in line with Marketing launch plans as necessary.
• Submitting documents and following up until obtaining approval for registration of drug products.
• Providing additional documents for product clearance, if required.
• Providing technical support/documents to all principals and new businesses as required.
• Preparing and submitting Medical Device diagnostic/classification to get a confirmation letter.
• Creating monthly reports to the Regulatory Affairs Manager about Medical registration.
• Being responsible for Medical Device Vigilance including submission of medical device event reports as required by the applicable local regulations and requirements to the Thai FDA and Supplier.
• Being responsible for Medicine vigilance and submission reports to Suppliers and the Thai FDA.

Qualifications

• At least a Bachelor’s Degree or higher in Sciences/Pharmaceutical or other related fields.
• 1-3 years of experience in regulatory affairs.
• Good command of computer literacy especially MS Excel.
• Superior interpersonal and communication skills.
• Ability to handle multiple projects and work under stress.
• Excellent proficiency in English verbal and written communication is required.