Regulatory Pharmacist

1 day ago


Pasig, National Capital Region, Philippines Himex Corporation Full time $104,000 - $130,878 per year

JOB DESCRIPTION - REGULATORY PHARMACIST

  • Prepare and submit documents to FDA such as license to operate, document for initial registrations, product registrations, GMPs, clearance applications, renewal of CPR including variation and compliance of existing product.
  • Monitor the status of applications with FDA
  • Checks updates and reports on regulatory input by subordinates in terms of product business plan.
  • Responsible in complying with the technical requirements of FDA or discuss and clarify matters with FDA when submitting technical requirements.

Qualifications

  • Graduate of Bachelor of Science in Pharmacy
  • Licensed Pharmacist
  • Knowledgeable in Risk Management Plan
  • With certificate of attendance to seminars, training, learning and development activities on medical device, safety and quality given by academe, industry, other organization.
  • With at least 2-3 years of experience in processing papers with FDA/Regulatory Pharmacist


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