Regulatory Affairs Sr. Officer

Job Description

Title: Regulatory Affairs Sr. Officer

Company Name: PT Combiphar

Vacancy: 3

Job Location: Jakarta Selatan

Career Level: Supervisor/Coordinator

Years Of Experience: 1 year

Qualification: Bachelor's Degree

Employment Status: Full-Time

  • Responsible to preparing on registration document (new product, variation and re-registration)
  • Searching information related to Regulation and Products registration requirement
  • Follow up to each Function for required documents for product registration
  • Prepare and Compose Registration Dossiers of Products intended for registration as per Country’s requirements
  • Support to Registration Manager in providing and updating Registration Documents 
  • Follow up to related functions for any Additional Data requests
  • Support to Registration Manager in submission and getting approvals for Administrative Registration Documents 
  • Submitting registration documents to local partners
  • Follow up status of product’s registration submission
  • Maintain communication with Partners for fulfillment of additional data required by country’s Regulatory Authorities

Job Requirements :

  • Bachelor Degree (S1) in Pharmacy / Apoteker Program
  • Having minimum 1 years experience in Pharmaceutical Industry
  • Must have knowledge of Criteria and Procedure of Product’s Registration (Drugs, Medical Device, Health Supplements, Traditional Medicines, Food, Household remedies)
  • Having Familiar with Registration Dossier; ACTD Dossiers for Drugs and CSDT for Medical Device
  • Having good skill in Microsoft Office
  • Must have a good communication skill in English (active and passive)

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