Lowongan Kerja Bogor Posisi Job Title Regulatory Affairs Associate, Thailand di Kemin

Overview

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