Overview

REGULATORY AFFAIRS PHARMACIST

Responsibilities

• Responsible for the company’s LTO application, renewal and variations.
• Responsible for handling product registration processes for Drugs, Medical Devices, Foods, Cosmetics including reviewing and preparing documentation and applications for submission to the FDA. Ensuring completeness, accuracy and adherence to regulatory guidelines.
• Prepare submissions of renewals of the CPR’s, monitor deadlines and ensure timely submission.
• Prepares submissions and communicate with distributors during the processing of CLIDP’s applications.
• Handles amendments / variations applications.
• Conduct thorough reviews of product labels (both primary and secondary packaging) for initial, CLIDP’s and renewal, verifying compliance with FDA labeling regulations, and proofreading all label content for accuracy and consistency before commercialization.
• Maintain a...