Regulatory Affairs Assistant
1 week ago
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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