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Regulatory Affairs Assistant - Taguig

Job Description Duties and Responsibilities:

  • Request for schedule in the FDA for promo submissions
  • Communicate to initiator regarding FDA submission
  • Preparation of promo application submissions
  • Promo application submissions to the FDA Provide information status of promo and registration submissions to RA team and to Marketing team Assistance to the RA Department, as needed
  • Assist on product label review
  • Assist on product registration upload in FDA portal
  • Administrative responsibilities, product filing in server, scanning of documents, filing of hard copies
  • Basic computations as required for product labels

Qualifications: Graduate of Pharmacy with minimum 6 months experience in Regulatory Affairs