Offer summary

Qualifications:

Pharmacist degree required., 2-3 years of experience in regulatory affairs., Proficiency in English and Thai languages., Strong understanding of FDA regulations and local laws..

Key responsabilities:

Ensure compliance with FDA and local regulations.

Evaluate and submit dossiers, both online and offline.

Respond to queries and meet with FDA staff for resolutions.

Represent clients in registrations and audits, and communicate with customers regarding FDA issues.

Job description

This is a remote position.

Description

Ensuring necessary compliance with FDA, local laws/authorities

Evaluating dossiers for submissions, submission of dossiers both offline/online, and following up for updates.

Responding to necessary queries, and meeting staff at FDA for resolution of queries.

Represent clients for all matters relating to registrations and audits and Communicate with customers within Thailand for resolving queries / FDA 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

Preferred Qualification
Pharmacist

Experience of 2-3 years

Language
English

Thai

An opportunity to Work from Home

Industry

Regulatory and Management Consulting

Employment Type

Full-time

Required profile