Regulatory Affairs
1 week ago
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.
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