Regulatory Affairs Assistant

1 week ago


Taguig, National Capital Region, Philippines Prime Manpower (A ManpowerGroup Licensee) Full time

Qualifications

Educational Background

  • Graduate of any Science course, preferably Pharmacy, or Food Tech or any allied professional science course

Work experience required

Minimum of 6 months working experience but new graduates are acceptable

Technical / Functional Skills

Behavioral Preferences / Soft Skills

*Other preferences (Age, gender, etc.)

QUALIFICATIONS

He or she has RA background/experience

Registration application with FDA and medical device

Background with Pharma industry

Health related industries or IBD/IVD

Not from FMCG industry

Roles and Responsibilities

JOB DESCRIPTION:

RA Assistant (Contractor post) supporting the Abbott Diagnostics Regulatory Affairs Team

  • 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
  • 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
  • Assistance to RAD, RAM and RAA, as needed
  • Has RA background/experience

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