Regulatory Pharmacist

1 week ago


Makati City, National Capital Region, Philippines The Cathay Drug Company, Inc. Full time ₱900,000 - ₱1,200,000 per year

FUNCTIONS:

  1. Maintenance of Product Registration
  2. Review and preparation of Registration Dossier and Variation applications
  3. Review of Distribution Records
  4. Maintenance of PV Reports
  5. Submission of Batch Notification
  6. Coordinate with toll manufacturer on Regulatory matters
  7. Coordinate closely with R & D Team
  8. Preparation of response to queries and concerns from Regulatory Authorities within the specified timeframe
  9. Liaise with RA counterpart of respective Principals
  10. Provide support to Sales and Marketing in matters relating to regulatory issues affecting  sales and promotion

QUALIFICATIONS:

  • Licensed Pharmacist
  • With experience / knowledge in:
  • Maintenance of Product Registration & FDA – issued License to operate
  • Compliance to PIC/s GMP Requirements
  • Pharmacovigilance
  • Preparation of facsimile labels for product registration purposes
  • Possesses good communication and leadership skills
  • Aggressive, analytical, hardworking and result oriented
  • Computer literate

We give our employees compensation packages:

  • Basic salary plus merit & meal and transportation allowances
  • 13th, 14th and 15th month bonuses
  • Career development and professional growth


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