The
Regulatory Officer is responsible for ensuring the companys compliance with regulatory requirements set by the Food and Drug Administration (FDA). The role involves processing and maintaining licenses such as License to Operate (LTO) and Certificates of Product Registration (CPR), preparing and submitting regulatory documents, monitoring updates in FDA regulations, and coordinating inspections and audits. The Regulatory Officer also maintains accurate compliance records, supports internal audits, and ensures timely renewal of permits to prevent operational disruptions.
Job Responsibilities
- Process and manage FDA licenses and product registrations including License to Operate (LTO) and Certificate of Product Registration (CPR).
- Ensure timely renewal of FDA permits and maintain an updated compliance tracker.
- Monitor FDA regulations, advisories, and circulars to ensure company compliance.
- Prepare, submit, and follow up FDA applications and regulatory documents.
- Serve as the company representative during FDA transactions, inspections, and audits.
- Maintain accurate regulatory records and documentation.
- Address FDA findings and support implementation of corrective actions.
- Assist in developing and updating FDA-related policies and SOPs.
Qualifications
- Bachelors degree in Pharmacy, Chemistry, Biology, Food Technology, Legal Management, or related field.
- Licensed professional (e.g., Pharmacist, Chemist, or other FDA-recognized license).
- At least 3 years of experience in FDA regulatory compliance and licensing.
- Experience handling FDA LTO, CPR, renewals, and regulatory documentation.
- Experience coordinating FDA inspections and audits.
- Strong organizational, documentation, and regulatory compliance skills.
NOTE : WE ARE SUBJECT FOR RELOCATION TO BGC ON APRIL
