Regulatory Affairs Pharmacist

Regulatory Affairs Pharmacist

Regulatory Affairs Pharmacist

Otsuka people creating new products
for better health worldwide

Thai Otsuka Pharmaceutical Company Limited is the worldwide pharmaceutical company. Our business includes manufacturing, trading, import and export of basic intravenous solutions, hospital products, therapeutic drugs and other pharmaceutical products. We are now looking for highly motivated and talented people to join our team.

Regulatory Affairs Pharmacist

Responsibilities:

  • To prepare, review, submit necessary documents and also provide information to principles as requested to the FDA and follow up until obtaining approval for registration. 
  • Reviewing the registration documents, approved licenses, certificate of analysis, promotional materials etc.   
  • Submitting restricted product report (new drugs) to FDA. 
  • Providing additional documents for hospital biding and tender id required from export countries.
  • Others as assigned for regulatory compliance activities.
  • Maintain and archive all registration documents for easy retrieval and ensure all regulatory information and guidelines are up to date.
  • Review all marketing printed and advertising materials to be in compliance with FDA and related regulations.
  • Coordinating with other departments in related with registration, amendment of approval licenses, promotion materials and advertisement permission. 
  • Verifying labels and packaging materials, promotion materials according to the FDA requirements for import product and approval.

Qualifications:

  • Bachelor’s Degree in Pharmacy, Pharmaceutical science.
  • At least 1 year experience in regulatory affairs or pharmacy manufacturing.
  • Dealing with Thai FDA Central Office.
  • Self-motivated, enthusiastic, highly responsible and team spirit.
  • Systematic, well-organized, service minded proactive, good discipline.
  • Good computer skill and good command of English.
  • Willing to do documents work and attention to details.
  • Driving license.

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