Offer summary

Qualifications:

Bachelor's degree in Pharmacy or related field, 2-3 years of experience in regulatory affairs, Proficient in English, Familiarity with BPOM/Ministry of Health regulations..

Key responsabilities:

Ensure compliance with BPOM/Ministry of Health regulations

Evaluate and submit dossiers for various products

Communicate with clients and authorities to resolve queries

Maintain documentation and update internal systems.

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