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REGULATORY AFFAIRS ASSISTANT MANAGER

Job Title: REGULATORY AFFAIRS ASSISTANT MANAGER
Location: Bangrak
Industry:
Salary: 60,000 – 70,000
Reference: JTH300003001478334
Contact Name: 307DB
Contact Email: 307DB@prtr.com
Job Published: September 22, 2017 17:22

Job Description

Company Background:

Our client is a global animal healthcare company that has been in business for more than 50 years. The company’s mission is to deliver quality medicines, complemented by diagnostic products and genetic tests supported by a range of services. The company is looking for energetic candidates to join the team.

Responsibilities:

  • Preparing registration dossier according to FDA requirements and documents for variation amendment of commercial products.
  • Ensuring that all key products are submitted following the company’s strategic plan.
  • Managing Thai FDA comments during the submission process and ensuring that products obtain registration approval within planned 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 updating packaging and artwork for registered products.
  • Performing other duties as assigned by supervisor.

Qualifications:

  • Thai nationality, aged 30 – 40 years old.
  • Bachelor or Master’s Degree in Pharmaceutical Science or any related field.
  • At least 3 years of experience in regulatory affairs/government contact.
  • Good interpersonal, negotiation, problem-solving and communication skills.
  • Good command of English, both written and spoken.