Regulatory Affairs Senior Officer – Domestic and Dossier

Regulatory Affairs Senior Officer – Domestic and Dossier

Job Summary

The Regulatory Affairs Senior Officer – Domestic and Dossier is responsible for managing regulatory submissions and dossier preparation for pharmaceutical and food supplement products intended for both Philippine and international markets. The role ensures compliance with Philippine FDA and country-specific regulatory requirements through the accurate, complete, and timely preparation of registration dossiers, renewals, and variations. The position works closely with internal departments, foreign manufacturers, and regulatory authorities to support successful product registrations, regulatory compliance, and business objectives.

Key Responsibilities

Regulatory Affairs and Compliance

·       Manage the preparation and submission of Philippine FDA applications for product registration, renewal, variation, and other regulatory transactions for pharmaceutical and food supplement products.

·       Ensure compliance with Philippine FDA and international regulatory requirements by monitoring, evaluating, and implementing updated regulations, guidelines, and circulars.

·       Coordinate with regulatory authorities, foreign manufacturers, and cross-functional departments regarding regulatory submissions, product compliance, and documentation requirements.

·       Review product labeling, artworks, packaging materials, and promotional documents to ensure compliance with applicable regulatory standards.

·       Support regulatory audits, inspections, licensing activities, and maintenance of legal and regulatory documentation.

Dossier Preparation and Document Management

·       Prepare, compile, review, and maintain regulatory dossiers for domestic and international submissions in ASEAN ACTD, CTD, and country-specific formats.

·       Evaluate technical documents including formulations, specifications, stability studies, COAs, test reports, and manufacturing documents for completeness, accuracy, and regulatory compliance.

·       Collaborate with QA, QC, Manufacturing, R&D, and other departments to secure, verify, and organize required regulatory documentation.

·       Ensure timely completion and submission of dossiers in accordance with regulatory timelines, company objectives, and market requirements.

·       Maintain regulatory databases, submission trackers, dossier archives, templates, and document control systems while ensuring compliance with internal SOPs and documentation standards.

Reporting and Team Support

·       Provide regular updates on registration status, submission timelines, and regulatory deficiencies to the Head of Regulatory Affairs and Upper Management.

·       Assist in training, mentoring, and supporting junior Regulatory Affairs personnel to ensure operational efficiency and regulatory compliance.

·       Contribute to the continuous improvement of regulatory systems, workflows, and compliance processes.

Qualifications

·       Licensed Pharmacist.

·       Minimum of 3–5 years of experience in Regulatory Affairs and dossier preparation for pharmaceutical and food supplement products.

·       Strong knowledge of Philippine FDA regulations, ASEAN ACTD, CTD, and country-specific dossier requirements.

·       Experience in handling product registrations, renewals, and variations for local and/or international markets.

·       Excellent organizational, coordination, and document management skills.

·       Strong communication, interpersonal, and problem-solving abilities.

·       Proficient in MS Office applications and document management systems.

·       Ability to work independently and manage multiple regulatory projects simultaneously.