Offer summary

Qualifications:

Bachelor's degree in Pharmacy or related field, 2-3 years of experience in regulatory affairs or drug compliance, Strong understanding of FDA regulations and local laws, Proficient in English communication skills..

Key responsabilities:

Ensure compliance with FDA and local regulations

Evaluate and submit regulatory dossiers, both online and offline

Respond to queries and liaise with FDA staff for resolution

Maintain documentation and records related to regulatory submissions.

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 Philippines 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

Travel to Bank for payments of FDA 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