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Regulatory Affairs - Indonesia

Genedrift

Role overview

Qualifications

  • Pharmacist
  • Experience in Drugs
  • Experience of 2-3 years
  • English language proficiency

Responsibilities

  • Ensuring necessary compliance with BPOM/Ministry of Health, local laws/authorities
  • Evaluating Drug Product, Herbal, Medical Devices, Cosmetics and/or Food Supplement dossiers for submissions
  • Responding to necessary queries and meeting staff at BPOM/Ministry of Health
  • Representing clients for all matters relating to registrations and audits

Key facts

Hard skills

Other skills

  • Communication
  • Problem Solving

About the company

Genedrift logo

Genedrift

  • Clinical Research (CRO)
  • Startup
  • 11–50
Genedrift has been a trusted Regulatory and Pharmacovigilance provider across the entire business value chain. Whether pre or post market approved product safety, complaints management, medical inquiry support and post market surveillance through submission. Your organization's business requirements are unique and we excel at developing customized solutions leveraging our experience and team to automate and streamline business processes, aligning to our clients strategic objectives and providing a business solution that seamlessly integrates as a part of your organization, leading to customer satisfaction.
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Job description

This is a remote position.

Description
Ensuring necessary compliance with BPOM/Ministry of Health, local laws/authorities
Evaluating Drug Product, Herbal, Medical Devices, Cosmetics and/or Food Supplement, dossiers for submissions, submission of dossiers both offline/online, and following up for updates.
Responding to necessary queries, and meeting staff at BPOM/Ministry of Health for resolution of queries.
Represent clients for all matters relating to registrations and audits and Communicate with customers within Indonesia for resolving queries / BPOM/Ministry of Health issues.
Ensure the upkeep and safe custody of all original documents and records
Stay updated and continuously update internal documentation with reference to the guidelines of FDA
Travel to Bank for payments of BPOM/Ministry of Health applications and update internal systems with all progress/updates.

Preferred Qualification
Pharmacist Experience in Drugs
Experience of 2-3 years

Language
English

An opportunity to Work from Home

Industry
 Regulatory and Management Consulting

Employment Type
 Full-time

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