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Regulatory Affairs - Thailand

Genedrift

Role overview

Qualifications

  • Pharmacist
  • Experience of 2-3 years
  • Language: English
  • Language: Thai

Responsibilities

  • Ensuring necessary compliance with FDA, local laws/authorities
  • Evaluating dossiers for submissions and following up for updates
  • Responding to necessary queries and meeting staff at FDA
  • Representing clients for registrations and audits

Key facts

Hard skills

Regulatory Compliance FDA Regulations

Other skills

  • Problem Solving
  • Communication

About the company

Genedrift logo

Genedrift

Contract Research Organizations (CRO)

Genedrift has been a trusted Regulatory and Pharmacovigilance provider across the entire business value chain. Whether pre or post market approved product safety, complaints management, medical inquiry support and post market surveillance through submission. Your organization's business requirements are unique and we excel at developing customized solutions leveraging our experience and team to automate and streamline business processes, aligning to our clients strategic objectives and providing a business solution that seamlessly integrates as a part of your organization, leading to customer satisfaction.

Company details

Company typeStartup
IndustryContract Research Organizations (CRO)
Company size11 - 50

Links

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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

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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