Regulatory Affairs Officer

The position is primarily responsible for handling regulatory related matters and executing licensing, permits, and product registration activities of assigned Business Partner with the end goal of having internal processes that consistently comply with all regulatory standards. Ensure overall compliance and maintenance of company’s Pharmacovigilance system, render required assistance to Marketing Team in product planning and monitor the progress of activities based on timelines.

KEY RESPONSIBILITIES:

• Handles all the activities related to relevant Licenses to Operate (LTO), permits, certificates of registration from opening or initial, monitoring of validity, notification, renewal, filing of amendments, sales promo permit and withdrawal. Secures and provides the necessary documents from the FDA and other regulatory agencies as needed in a bid.
• Maintains complete and orderly file of documents both obsolete and current for the Department. Ensures a...