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Regulatory Affairs - Philippines

Key Facts

Remote From: 
Full time
English

Other Skills

  • •
    Communication
  • •
    Problem Solving

Roles & Responsibilities

  • Pharmacist
  • 2-3 years of experience in Drugs
  • English language proficiency

Requirements:

  • Ensure compliance with FDA and local laws
  • Evaluate and submit dossiers
  • Respond to queries from FDA
  • Represent clients in registrations and audits
  • Maintain original documents and records
  • Update internal documentation regarding FDA guidelines
  • Travel to bank for FDA application payments

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

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