Senior Regulatory Specialist

Largen Med Inc.; Quezon City; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

Largen Med Inc. is seeking an experienced Senior Regulatory Affairs Specialist to manage regulatory requirements across pharmaceutical, food supplement, medical device, and related healthcare products for the Philippine market.

You will independently handle submissions, coordinate with suppliers and government agencies, monitor timelines, and ensure products are compliant and ready for commercialization. A strong background in regulatory affairs and meticulous documentation is required to

Qualifications

• Experience managing regulatory submissions with the Philippine FDA.
• Ability to prepare and organize regulatory dossiers for drugs, supplements, and devices.
• Track record ensuring timely renewals and regulatory approvals.
• Strong coordination with suppliers and government agencies.

Responsibilities

• Manage product registration, renewal, variation, and other regulatory submissions with the Philippine FDA.
• Prepare, review, and organize regulatory dossiers for healthcare products.
• Monitor CPRs, LTOs, permits, and renewals to ensure timely processing.
• Coordinate with suppliers on regulatory documents and timelines.
• Handle FDA queries and regulatory correspondence through to approval.
• Review labels, packaging, and marketing materials for compliance.
• Maintain a regulatory monitoring system with submission status and deadlines.
• Evaluate new products for regulatory requirements and timelines.
• Support Business Development with regulatory assessments of products and suppliers.
• Assist in importation regulatory documentation and compliance.
• Monitor FDA regulations and report impacts to management.
• Ensure organized regulatory records for audits and inspections.
• Guide junior regulatory personnel when needed.
• Provide regular status reports highlighting priorities and risks.

Skills

Regulatory submissions

Philippine FDA liaison

Documentation management

Cross-functional coordination

Tools

Regulatory databases

Job description

Largen Med Inc. is looking for an experienced Senior Regulatory Affairs Specialist to manage and support the regulatory requirements of our pharmaceutical, food supplement, medical device, and related healthcare product portfolio.

This role is ideal for a regulatory professional who can independently manage submissions, coordinate with suppliers and government agencies, monitor regulatory timelines, and help ensure that products are compliant and ready for commercialization in the Philippine market.

Key Responsibilities

• Manage product registration, renewal, variation, amendment, and other regulatory submissions with the Philippine FDA
• Prepare, review, and organize regulatory dossiers and supporting documents for drugs, food supplements, medical devices, and other healthcare products
• Monitor Certificates of Product Registration (CPRs), Licenses to Operate (LTOs), permits, certificates, and other regulatory requirements to ensure timely renewal
• Coordinate directly with international and local suppliers regarding regulatory documents, deficiencies, technical requirements, and submission timelines
• Handle FDA queries, deficiencies, follow-ups, and regulatory correspondence until completion or approval
• Review product labels, packaging materials, claims, inserts, and marketing materials for regulatory compliance
• Maintain an updated regulatory monitoring system showing submission status, pending requirements, approvals, renewals, and deadlines
• Evaluate new products for Philippine regulatory requirements, registration feasibility, documentation requirements, and estimated timelines
• Support the Business Development team by conducting regulatory assessments of potential products and suppliers
• Assist in importation-related regulatory documentation and compliance requirements
• Monitor relevant Philippine FDA regulations, circulars, advisories, and policy updates and communicate their impact to management
• Ensure complete and organized regulatory records for internal reference, audits, and inspections
• Guide and review the work of junior regulatory personnel when necessary
• Provide regular, concise regulatory status reports to Management, highlighting priorities, delays, risks, and required actions