Regulatory Affairs and Compliance

Job Description

• Handles all the activities related to relevant Licenses to Operate (LTO), permit, certificates of registration from 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.
• Maintains complete and orderly files documents such as the FDA regulatory requirements, memo, Administrative Order (AO), Republic Act (RA), or management system standard.
• Ensure availability of valid regulatory documents including SOP's, CPRs, LTO, GMPs, and other related certificates.
• Perform other tasks that might be assigned from time to time such as audit

Qualification

• BS Pharmacy, BS Food Technology, BS Chemistry, BS Nutrition, or any related course.
• Experience in FDA application, product registration, CPR/CPN processing is an advantage.
• Strong attention to detail and knowledge of regulatory requirements.