Regulatory Specialist

Benitua-Gan Ventures, Inc.; San Pedro; On-site; PHP 350,000 - 580,000; Full time

Job summary

Genie PH is seeking a Regulatory Specialist to ensure compliance with Philippine FDA and other regulatory requirements. You will manage product registrations, LTO, regulatory dossiers, labeling review, and regulatory submissions, coordinating with internal teams and external agencies.

The role requires a Bachelor’s degree in a related field and 2–3 years of regulatory affairs experience, with knowledge of FDA processes, GMP, and labeling regulations.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2–3 years of experience in Regulatory Affairs within food/pharma/cosmetics manufacturing.
• Experience with Philippine FDA product registration and LTO management preferred.
• Knowledge of Philippine FDA regulations for Food Supplements.
• Knowledge of Product Registration and License to Operate (LTO) requirements.
• Knowledge of Food Supplement labeling regulations.
• Knowledge of GMP.
• Proficiency in Microsoft Office.
• Proficiency in FDA eServices Portal.
• Detail-oriented with excellent documentation skills.

Responsibilities

• Prepare and submit Philippine FDA applications and regulatory documents.
• Manage product registration and License to Operate (LTO) requirements.
• Compile and maintain regulatory dossiers and supporting documents.
• Review product labels and packaging artwork for regulatory compliance.
• Assess products, processes, and documentation against applicable regulatory requirements.
• Monitor and maintain regulatory permits and renewal requirements.
• Conduct regulatory research and interpret changes in applicable regulations.
• Prepare regulatory correspondence, responses, and other required submissions.
• Maintain proper document control, records, and version management.
• Coordinate with internal departments and external regulatory agencies.

Skills

Regulatory affairs

Philippine FDA

Documentation

GMP knowledge

Attention to detail

MS Office

Education

Bachelor's degree in Life Sciences

Tools

FDA eServices Portal

Job description

About the role

We are looking for a detail-oriented and organized Regulatory Specialist to ensure compliance with Philippine FDA and other applicable regulatory requirements. The role will manage product registrations, License to Operate (LTO), regulatory documentation, labeling compliance, regulatory submissions, permit renewals, and regulatory intelligence. The Regulatory Specialist will coordinate with internal departments and external agencies to ensure that our products, facilities, and operations remain compliant with applicable laws, regulations, and industry standards.

Key responsibilities

• Prepare and submit Philippine FDA applications and regulatory documents.
• Manage product registration and License to Operate (LTO) requirements.
• Compile and maintain regulatory dossiers and supporting documents.
• Review product labels and packaging artwork for regulatory compliance.
• Assess products, processes, and documentation against applicable regulatory requirements.
• Monitor and maintain regulatory permits and renewal requirements.
• Conduct regulatory research and interpret changes in applicable regulations.
• Prepare regulatory correspondence, responses, and other required submissions.
• Maintain proper document control, records, and version management.
• Coordinate with internal departments and external regulatory agencies.

About you

• Bachelor's Degree in Food Technology, Pharmacy, Chemistry, Biology, Nutrition, Chemical Engineering, or other related science courses.
• At least 2–3 years of experience in Regulatory Affairs within the food, food supplement, pharmaceutical, cosmetic, or related manufacturing industry.
• Experience with Philippine FDA product registration and LTO management is preferred.
• Knowledge of Philippine FDA regulations for Food Supplements.
• Knowledge of Product Registration and License to Operate (LTO) requirements.
• Knowledge of Food Supplement labeling regulations.
• Knowledge of Good Manufacturing Practices (GMP).
• Proficiency in Microsoft Office.
• Proficiency in FDA eServices Portal.
• Detail-oriented with excellent documentation skills.

About us

At Genie PH, we value Accountability, Growth, and excellence, while fostering a culture of empowerment, innovation, partnerships, and commitment.