Regulatory Pharmacist

About the role

The Regulatory Officer will be responsible for ensuring that cosmetics, fragrances, and personal care products comply with Philippine FDA regulatory requirements. The role involves product notification, regulatory documentation, labeling review, permit processing, and coordination with the FDA and other relevant agencies.

Key responsibilities

• Prepare, submit, and monitor FDA Cosmetic Product Notification (CPN) applications for cosmetics and fragrances.
• Process and maintain the company's FDA License to Operate (LTO) and other applicable regulatory permits.
• Ensure all cosmetic and fragrance products comply with applicable Philippine FDA and ASEAN Cosmetic Directive (ACD) requirements.
• Review product formulations and ingredient lists to verify regulatory compliance.
• Review product labels, packaging, product claims, and promotional materials before market release.
• Prepare and maintain regulatory documents, including Product Information File (PIF), product formulation and ingredient lists, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), Certificates of Free Sale, GMP and other supplier/manufacturer certificates, and supporting documents required for FDA submissions.
• Coordinate with overseas suppliers and manufacturers to obtain complete and compliant regulatory documents.
• Monitor the status of FDA applications, notifications, renewals, and regulatory submissions.
• Coordinate with the Philippine FDA regarding regulatory inquiries, deficiencies, clarifications, and compliance requirements.
• Ensure that imported cosmetics and fragrances have the necessary regulatory documentation before shipment or distribution.

About you

• Bachelor's degree in Pharmacy or a related field.
• At least 1–3 years of experience in FDA regulatory affairs, preferably in Fragrances, Cosmetics, Skincare or personal care.
• Experience handling FDA CPN applications and LTO processing.
• Experience dealing with international cosmetic suppliers and obtaining regulatory documents.
• Familiarity with Philippine FDA cosmetic product notification requirements and ASEAN Cosmetic Directive requirements.
• Familiarity with importing cosmetics and fragrances into the Philippines.
• Experience preparing and reviewing FDA regulatory documents.
• Knowledge of cosmetic ingredients, labeling, product claims, and regulatory requirements.
• Strong attention to detail and excellent documentation skills.
• Proficient in Microsoft Office.