Regulatory Pharmacist

Scent and Beaute Inc.; Makati; On-site; PHP 800,000 - 1,100,000; Full time

Job summary

Scent and Beaute Inc. in Makati, Philippines, is seeking a Regulatory Officer to ensure cosmetics, fragrances, and personal care products meet Philippine FDA requirements.

You will manage product notifications, regulatory documentation, labeling reviews, permit processing, and liaise with the FDA and agencies. The role requires a Bachelor's degree in Pharmacy or related field, 1–3 years in FDA regulatory affairs, experience with CPN applications and LTO, and coordinating with international

Qualifications

• Bachelor's degree in Pharmacy or related field.
• 1–3 years of FDA regulatory affairs experience.
• Experience handling FDA CPN applications and LTO processing.
• Experience coordinating with international cosmetic suppliers.

Responsibilities

• Prepare, submit, and monitor FDA Cosmetic Product Notification (CPN) applications for cosmetics and fragrances.
• Process and maintain FDA License to Operate (LTO) and other permits.
• Ensure compliance with Philippine FDA and ASEAN Cosmetic Directive (ACD) requirements.
• Review formulations and ingredient lists for regulatory compliance.
• Review labels, packaging, product claims, and promotional materials before market release.
• Prepare and maintain regulatory documents (PIF, formulation and ingredient lists, COA, SDS/MSDS, Certificates of Free Sale, GMP and other certificates).
• Coordinate with overseas suppliers and manufacturers to obtain 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 imported cosmetics and fragrances have necessary regulatory documentation before shipment.

Skills

Regulatory affairs

FDA CPN handling

LTO processing

Supplier coordination

Regulatory labeling review

Education

Bachelor's degree in Pharmacy or related field

Job description

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.