Our client is a prominent of FMCG company in Indonesia which is specialized in skincare industry
Job Description :
To assist RA & DC Quality Manager in managing Regulatory Affairs & DC Quality Management activities, including product registration/notification of products to be sold in local market and to be exported, quality management system & project Halal.
The responsibility may cover :
A. Regulatory Affairs :
- To support marketing on Launch & Re-launch project such as provide regulatory advice and Artwork/product claim review
- To compile & file product registration dossier of the company products which is intended to be sold in local market and intended to be exported to other countries
- To execute product registration/notification process
- To process request of export documents from respective countries and ensure that the process is on track and complete.
- To submit application of Certificate of Free Sale to BPOM/Kemenkes and legalization process to relevant ministry & embassy
- To submit advertising material to Authority for pre-approval.
- To compile & file dossier related to company licenses and follow up the proces to Authority (Izin Penyalur, Izin Produksi, CPOB, CPKB, etc)
- To submit regular report regarding MESO, production & distribution of products to Authority
B. Quality Management System :
- To compile & file Quality Management System documentation.
- To do market visit for on-shelf quality check and report to DC Quality Manager.
- Candidate must possses at least Diploma Degree in all major from reputable university
- Max. 27 years old
- Fluent in English (both oral and written)
- Have min. 1 year experience in Pharmacy an Chemistry Industry.
- Familiar with product registration process and Quality Management System
- Computer literate