Regulatory Affairs - Indonesia
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
Preferred Qualification
Pharmacist
Experience in Drugs
Experience of 2-3 years
Language
English
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. Other Skills
- Communication
- Problem Solving