Regulatory Pharmacist

5 days ago

Pasig, Philippines Wellpro Biomedical Inc Full time

Responsibilities

Your responsibilities will include:

  • Prepares & submits documents to Philippine Food and Drug Administration (FDA) such as License to Operate (LTO) & drug product - ACTD document for Initial registration, Site Registration/GMP Clearance applications, BA/BE study report, renewal of CPR, including variations and compliance of existing products.
  • Must know or have an experience applying Initial and renewal application for drug products.
  • Monitors the status of applications with the FDA.
  • Creates and reviews packaging layouts in line with existing standards set by FDA.
  • Handles company inspection and audit relevant to third party and government agencies.
  • Handles applications with Intellectual Property Office (IPO) for trademarks and other functions of the agency.
  • Directly reports to Regulatory Manager.
Qualifications

To be successful in this role, you will need to have:

  • Bachelor’s Degree in Pharmacy or any related courses in Medical Field.
  • At least 2 years of working experience as Regulatory Compliance Officer.
  • Detail oriented and attention to accuracy.
  • Excellent communication and interpersonal skills.
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