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06 January 2020
Job ID: RY-8161
Senior Regulatory Affair Specialist (100-150K)/ Medical Devices and Pharmaceuticals

Position:       Senior Regulatory Affair Specialist (100-150K)

Business:       Medical Devices and Pharmaceuticals

Location:        Rayong

Contact:         Morakot 095 462 4239 – Morakot (at) mriww co th

 

Summary

Responsible for the implementation of complex regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of company’s products.

 

Essential Duties and Responsibilities

  • Maintain RA database per global and local requirement
  • Act as point of contact between plant, local commercial RA and export countries
  • Maintain all licenses with Thai FDA
  • Approve and lead key projects/variation on behalf of Plant.
  • Work closely with manufacturing site and global RA to obtain documentation and facilitate submission process
  • Contribute to development of RA strategies for assigned projects
  • Liaise with Baxter Corporate RA and other colleaques on site to ensure open and up to date communication of the status of relevant processes are being put into action
  • Keep abreast of changes in regulation and standards and ensure relevant colleagues being advised of implications of such changes

 

Qualifications

  • Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with a minimum of 5 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization.
  • Background in local pharmaceutical manufacturing will be an added advantage
  • Knowledge of ACTD & ACTR; ACTD dossier preparation for drug registration in ASEAN would be a plus
  • Exercise independent judgment
  • Scientific knowledge
  • Written and Verbal communication skills
  • Knowledge of regulations
  • Strong Negotiation skills
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Manage multiple projects and deadlines
  • Ability to identify compliance risks and escalate when necessary

 

Candidates who match the above description, please send updated resume, including recent photo and detailed income to Morakot (at) mriww co th

 

For more information, call 095 462 4239

Apply Now

Job Details:

Benefits:
  • Gratuity
  • Housing allowance
  • Medical insurance

MRI Worldwide Recruitment (Thailand) Ltd.
http://mrinetwork.com/mrithailand/
For over fifty years, we have been a world leader in the field of executive search, and have provided high-caliber candidates to literally thousands of companies. We have International reach which is unparalleled in our industry. MRINetwork has been operating for 12 years in Thailand. As a client we find the best quality candidates quickly and as a candidate our recruiters will assist you in any way they can in your career transition. For more information, please call 66 (0) 2651 9889  [email protected]

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