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