Regulatory Officer

  • Jakarta
  • Luxasia
Description of Duties:Regulatory OperationalDocuments Preparation: requesting new product launching Registration document requesting new product launching product sample (especially skincare) requesting contain of formula, Product Spec, CFS, GMP, LOA Registration document and completion of PIF drafting ingredients in the formula for each SKU Formulation recheck-submitting formula, putting the size/packaging, checking claims, choosing the category of the product submission to BPOM Regulatory Process Products submission to BPOM online system Process & follow up payment fee of the registration Verify & follow-up to BPOM related with the payment process checking and follow-up through BPOM system Product ID Follow-up the notification progress of notification approval Follow-up the postponed product and its settlement Updating notification database Product notification list/database Process the KIT letter based on information from Marketing team, to issuing the BPOM Certification Registering new manufacturer by giving GMP New manufacturer Maintain files tracking of notification certificate from BPOM system to company internal folder (pdf files certificate) Requesting, checking, and preparing supporting document Supporting data for product claims Distribute an updated information intime to related department for compliance BPOM labelling requirement of product in market Verify that all documentation adheres to import policies, legal, and regulatory compliance RequirementsEducation & Experience: Minimum Bachelor's Degree in Pharmacy, preferably Apothecary At least 2-3 years of working experience in the same position, preferably in Cosmetic Industry. Fresh graduates with internship experience are welcome to apply. Have the experience and familiar with BPOM processKnowledge and Skills: Good manner & fluently in speaking, negotiating, and discussion with Government Officer and principal Good analytical skills, detail oriented particularly with checking-detail, and computer literate Thrive for success, able to work under-pressure, and positive toward change and challenge Fluent in English both oral and written Initiative and have efficiency in working attitude Filing documents attitude in orderly