FDA Regulatory Affairs Officer / Regulatory Pharmacist - URGENT

Dayabumi Distribution Mabulo Inc.; Camarines Sur; On-site; PHP 550,000 - 900,000; Full time

Job summary

Dayabumi Distribution Mabulo Inc. is urgently hiring a Regulatory Affairs Officer / Regulatory Pharmacist to oversee Philippine FDA regulatory requirements for cosmetics and pharmaceutical products.

You will manage CPNs, LTOs, labeling, and regulatory documentation to bring products to market efficiently while maintaining strict compliance. The role requires hands-on experience with FDA processes, strong documentation skills, and the ability to coordinate with the regulator across eServices and

Qualifications

• Must have regulatory knowledge for cosmetics and pharmaceutical products
• Experience with CPN and LTO processes for cosmetics
• Strong documentation and regulatory filing skills
• Familiarity with Philippine FDA requirements and labeling rules
• Detail-oriented with ability to manage multiple SKUs and deadlines

Responsibilities

• Handle end-to-end FDA Certificate of Product Notification (CPN) applications for cosmetics products
• Manage new registrations, renewals, amendments, and variations
• Assist in maintaining and renewing the company’s FDA License to Operate (LTO)
• Prepare, organize, review, and submit regulatory dossiers and supporting documents
• Coordinate with Philippine FDA via online/eServices systems
• Maintain an organized regulatory tracker for all products and statuses
• Assist in audit readiness for FDA inspections and post-market activities
• Identify compliance risks and suggest process improvements

Skills

Regulatory affairs

FDA experience

Pharmacist

Labeling/claims review

Documentation

Education

Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Biology, Chemical Engineering

Tools

FDA eServices

Job description

URGENT HIRING: REGULATORY AFFAIRS OFFICER / QUALIFIED PERSON – FDA & PRODUCT COMPLIANCE (COSMETICS & PHARMACEUTICAL PRODUCTS)

Location: Camarines Sur, Bicol Region

Product: Cosmetics & Pharmaceutical Products (bar soaps, etc)

We are looking for a Regulatory Affairs Officer / Regulatory Pharmacist who can take charge of our Philippine FDA regulatory requirements and help bring cosmetics products to market faster—while ensuring everything we launch stays compliant.

If you know your way around FDA product registration, CPNs, LTOs, product labels, claims, and regulatory documentation, we’d love to meet you.

Key Responsibilities:

Philippine FDA Regulatory Affairs

• Handle end-to-end FDA Certificate of Product Notification (CPN) applications for cosmetics products
• Manage new registrations, renewals, amendments, and variations
• Assist in maintaining and renewing the company’s FDA License to Operate (LTO)
• Prepare, organize, review, and submit regulatory dossiers and supporting documents
• Manage applications and follow-ups through applicable FDA online/eServices systems
• Communicate and coordinate with the Philippine FDA regarding applications, deficiencies, clarifications, and compliance matters
• Maintain an organized regulatory tracker for all our products, including registration status, expiration dates, renewals, and pending requirements

Product & Label Compliance

• Review product formulations and ingredients before commercialization to identify potential regulatory issues
• Review labels, packaging, nutrition information, ingredient declarations, warnings, and mandatory statements
• Evaluate marketing and product claims to ensure they are compliant with Philippine FDA requirements

• Flag ingredients, dosages, claims, or formulations that may create registration issues before products enter production

Compliance & Regulatory Intelligence

• Keep the company updated on new and changing Philippine FDA regulations, circulars, administrative orders, and requirements.
• Help prepare the company for FDA inspections and post-market surveillance activities
• Maintain complete and audit-ready regulatory records
• Identify potential compliance risks before they become problems
• Recommend improvements to our internal regulatory processes as the company and product portfolio grow

Requirements:

• Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Biology, Chemical Engineering, or another relevant food/science-related course
• A valid Professional Regulation Commission (PRC) ID is strictly mandatory for the designated company Qualified Person.
• Certificates of attendance to seminars, trainings, and development activities.
• Ideally 1-2+ years of Regulatory Affairs experience in cosmetics products (bar soaps). Fresh graduate welcome to apply.
• **Strong**Hands-on Philippine FDA experience is highly preferred
• Experience preparing and submitting CPN and/or LTO applications
• Familiarity with Philippine FDA requirements for cosmetics
• Strong understanding of product labeling and health claims
• Highly organized and comfortable managing multiple SKUs, deadlines, and applications simultaneously
• Strong written communication and documentation skills
• Detail-oriented—you’re the type of person who notices the one incorrect word on a label before 50,000 units get printed