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REGULATORY AFFAIRS MANAGER

Job Title: REGULATORY AFFAIRS MANAGER
Location: Bangkok
Industry:
Reference: JTH300003001456407
Contact Name: 364DB
Contact Email: 364DB@prtr.com
Job Published: August 28, 2017 16:08

Job Description

Company Background

Our client is a leading generic pharmaceuticalcompany with more than 20 years in business. As part of their continuing growth, the company is now seeking a well-organized and highly talented person for the position of Regulatory Affairs Manager

Location:Pattanakarn

Salary60,000 - 80,000 Baht / month

Job Description:- 

This position is responsible for regulatory tasks by coordinating internally with the RA team at the head office and TFDA to ensure the dossier submission is within timeline to meet the marketing objectives and timeline of the launch plan for product portfolio.

  • Studying scientific and legal documents.
  • Gathering, evaluating, organizing, managing and collating information in a variety of formats.
  • Ensuring compliance with TFDA regulations
  • Maintaining familiarity with company product ranges
  • Planning, undertaking and overseeing product trials and regulatory inspections
  • Keeping up-to-date with changes in regulatory legislation and guidelines
  • Liaising and negotiating with regulatory authorities
  • Ensuring that quality standards are met and submissions meet strict deadlines
  • Providing advice about regulations to manufacturers/head office RA team
  • Preparing documentation properly 

Requirements:-

  • Thai nationality, male/female
  • Bachelor’s degree in Pharmaceutical Science
  • 10 years and above of RA experience in the pharmaceutical industry
  • Good command of English, both written and spoken
  • Computer proficiency  

Qualified candidates please submit your resumes stating present and expected salary & package details via APPLY NOW

P.RRecruitment and Business Management Co., Ltd.

2034/82 Ital - Thai Tower, 18th Floor, New Petchburi Road,

Bangkapi, Huaykwang, Bangkok 10320

Tel. 02-7160000 Fax. 02-7160056

Website: WWW.PRTR.COM

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