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REGULATORY AFFAIRS ASSISTANT MANAGER

Job Title: REGULATORY AFFAIRS ASSISTANT MANAGER
Location: Bangrak
Industry:
Reference: JTH300003001414214
Contact Name: 241DB
Contact Email: 241DB@prtr.com
Job Published: July 05, 2017 11:35

Job Description

Company Background: 

Our client is a global animal health company that has been in business for more than 50 yearsThe companydelivers quality medicines, complemented by diagnostic products and genetic tests that are supported by a range of servicesNow they are looking for energetic candidates to join the team as its Regulatory Affairs Assistant Manager. 

Responsibilities:

  • Preparing registration dossiers according to FDA requirements and documents for various amendments of commercial products.
  • Ensuring that all key products are submitted followinga strategic plan.
  • Managing Thai FDA comments along the submission process and ensuringthat the company’s products obtain registration approval within timeline.
  • Liaising with the regulatory authorities to obtain registration certificate approval or amendment approval.
  • Ensuring regulatory compliance for all products with the current laws and regulations.
  • Supporting product importation by ensuring that all documents are aligned with local requirements.
  • Arranging and updatingregistered products’ packaging artwork.
  • Performing other duties as assigned by supervisor.

Qualifications:

  • Male or female, age not over 35 years old.
  • Bachelor’s or Master’s Degree in Pharmaceutical Science.
  • At least 3 years experience in regulatory affairs.
  • Responsible, hard-working and well-organized.
  • Good command of English, both writing and speaking.
  • Good interpersonal, negotiation, decision-making and problem solvingskills.