Regulatory Affairs Officer

Job Summary

Assists the Senior Regulatory Officer in product registrations and securing operational licenses with various Regulatory Agencies (FDA, DENR, BAI) for the assigned Business Units or Product Categories. Use pharmacist license for LTO and registration of Cosmetics and Personal Care products. Assists Marketing in finalizing product labels, and product claims, and securing supporting documents by FDA guidelines.

Duties and Responsibilities

1. To prepare the registration dossier of new products and Certificate of Product Registration (CPR) renewals, file dossiers with the FDA, and ensure that certificates are released and updated.
2. Ensure that the company’s Licenses to Operate for all Business Units are renewed and updated on time.
3. To take charge during inspection visits of FDA representatives. Ensure that all documents are ready and that the office and warehouse are in order.
4. To inform Management of any new guidelines, or rulings being issued by the FDA about product registrations and licenses affecting our product categories
5. To represent the company in FDA forums; attend seminars and workshops required by FDA.
6. To establish a Tracking Monitoring System for all licenses and Certificates of Product Registration (CPR) for all CCPI products.

Qualifications

1. A licensed Pharmacist
2. Good in planning and organizing
3. Preferably has experience in dealing with the FDA
4. Assertive, resourceful, and has initiative
5. With good oral and written communication skills
6. Pleasant personality