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Regulatory Affairs - Indonesia

unlimited holidays - extra holidays - extra parental leave - long remote period allowed
Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Pharmacist, 2-3 years experience in Drugs.

Key responsabilities:

  • Ensure compliance with local laws
  • Submit dossiers and follow up with updates
  • Represent clients for registrations and audits
  • Maintain custody of original documents
  • Update internal documentation with FDA guidelines
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11 - 50 Employees
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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

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

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