DO NOT APPLY IF YOU DON'T HAVE EXPERIENCE AS A REGULATORY PHARMACIST !

Duties and Responsibilities

• Able to secure quality documents/samples for Initial Registration, Amendments, Variations, Inclusions, Exhaustion, Shelf life Extension, PCPR, CLIDP's and the like.
• Able to submit compliance on or before the deadline prescribed by the FDA correctly and in a time efficient manner.
• Responsible to liaise necessary applications and to follow up all applications to FDA.
• Responsible for securing Licenses and or Renewals of the same (ie FDA Drugs, Cosmetics, Foods, DOH Accreditation's, DOH-Medical Devices, PDEA)
• Ensures that products being placed by the Import Department has the CPR prior to the arrival.
• Able to communicate with the suppliers and guide them accordingly on the Regulatory Requirements on the Registration of PDEA, BAI, and DOH Products.
• Secure quality documentation prior to application of Initial registration (FDA and DOH)