Regulatory Affairs Associate, Thailand

Overview:
LI-KT1

**Responsibilities**:
**Overall responsibility**
- Responsible as Licensed Pharmacist, and represent the company for Thai FDA related matters
- Submit product registration through TFDA
- Support the regulatory activities of the company - Thailand effectively.
- Update management on Regulatory and GDP policy changes.

**Product Registration**
- Submitting documents and follow up until obtaining approval for registration of animal vaccines/biological products
- Submitting documents for amendment of approved licenses.
- Providing information to global RA team as requested.

**Support Import activities (Lot release/License per invoice activities)**
- Check and translate Certificates of Analysis.
- Support lot release activities, incl. obtaining data logger and coordination for lot release
- Submitting monthly, quarterly, half-year and annual importation and sales reports to FDA.

**Support Thai FDA/GDP inspection**
- Working with external warehouse to support internal and external GMP audits or inspections.
- Support internal and external safety activities in collaboration with internal and external stakeholders.

**PV/AE reporting and complaint handling**
- Support Kemin Thailand in complaint handling
- Collection, reporting and handling of safety information associated with company in-licensing products and track AE cases and perform case follow-ups as needed.
- Perform regular reconciliation activities as required by Kemin procedures and local regulatory authority requirements.
- Assume responsibility for PV related educating and training for relevant personnel.

Qualifications:

- Bachelor’s degree of Pharmacy or related fields.
- Preferably having experience in Animal health product, (especially, vaccines) registration
- Good communication skills
- Good relationship with FDA will be advantage.
- Ability to manage work/ project priority
- Ability to handle multi stakeholders