Regulatory Affairs Pharmacist

Admin/ May 13, 2022/


  • Handle the registration and renewal of assigned products and licenses to FDA
  • Collate and evaluate registration documents from the principal
  • Check the quality of promotional materials such as brochures, product leaflets if in accordance with the regulation of FDA
  • Prepare and edit labeling materials for FDA submission
  • Follow-up and monitor the status of product and LTO registration applications to FDA
  • Check the quality of Returned Upon Delivery vaccines/biological before it can be transferred to trade stocks
  • Quality audit of assigned principals
  • Keep retention samples of each batch of assigned products
  • Maintain database like FDA applications and certificates
  • Provide an update to principals and multiple departments regarding the status of registrations, new developments such as policies and regulations
  • Assist in the conduct of Clinical Trials
  • Create or implement regulatory affairs rules and procedures


  • Graduate of Bachelor’s Degree in Pharmacy; Must be a Registered Pharmacist
  • With at least 2 years related experience in Regulatory
  • Familiarity with FDA processes, policies ad regulations
  • Strong regulatory knowledge in product registration and licensing
  • Must be detail-oriented and organized
  • Good communication skills

Apply for this position

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