Senior Regulatory Specialist

2 weeks ago


Pasig, Philippines TOTAL NUTRITION CORPORATION Full time

Senior Regulatory Specialist Ensure that the Regulatory Department is doing their assigned duties and responsibilities Direct reporting to General Manager and Regulatory Affairs Head from parent company Food Registrations (FDA) – preparation of documents and actual sample for submission Initial Applications Renewal Applications Reapplications (submissions with compliance) Drug Registrations (FDA) – preparation of documents and actual sample for submission Initial Applications Renewal Applications Reapplications (submissions with compliance) Cosmetic Registrations (FDA) – preparation of documents and actual sample for submission Initial Applications Renewal Applications Reapplications (submission with compliance) LTO (FDA) – communicate with front end staff regarding FDA concerns Initial Applications Renewal Applications Variations (Notice of Change of Pharmacist, transfer of location) CAPA (compliance during inspection) Attend meetings/ seminars within and outside organization Facilitate Store Inspections (competitors) to check latest products available Prerequisites: Ability to work efficiently in a high-pressure, fast paced, deadline driven environment. Good written and verbal communication skills. Excellent people and management skills. Possess knowledge on the following: FDA Guidelines FDA Procedures and Registration Process Academic qualification: BS PHARMACY Graduate Pharmacist's Licensure Exam Passer Years of experience: 4yrs and above Job Types: Full Time #J-18808-Ljbffr


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