Executive Search Firm Monroe Consulting Group is recruiting a Regulatory Affairs - Dossier Team Leader in behalf of a regulatory-focused company of a multinational pharmaceutical group. The Dossier Team Leader oversees dossier preparation for both Philippine and international market submissions, ensuring high-quality, compliant, and timely compilation of regulatory documents for product registration, renewal, and variations. The role ensures accurate, complete, and compliant dossiers in coordination with the RA Head and Regulatory Affairs team. Working setup is onsite in Ortigas, Pasig City.
Key Responsibilities:
- Supervise and coordinate the Dossier Team handling both domestic and export markets dossiers.
- Plan, assign, and monitor dossier preparation activities for drugs and food supplements based from RA targets
- Review dossiers for completeness and compliance with country-specific requirements (e.g., ASEAN ACTD, CTD, or local formats).
- Coordinate with Regulatory Managers (Domestic and International), QA, QC, Manufacturing, and R&D to gather and verify technical documents.
- Ensure timely dossier submissions to meet registration targets and renewal timelines.
- Maintain dossier templates, trackers, and submission archives.
- Conduct internal review of data (formulations, test reports, stability, COAs, etc.) prior to submission.
- Provide technical and procedural training to Dossier Specialists.
- Ensure compliance with internal SOPs and documentation standards.
- Report to RA Head and Upper Management Team
Qualifications:
- Licensed Pharmacist
- Minimum 5 years of experience in dossier compilation for both local and international markets.
- Knowledgeable in ASEAN ACTD, CTD, and country-specific dossier formats.
- Excellent organization, coordination, and document control skills.
- Strong leadership, communication, and multitasking abilities.
- Proficient in MSOffice and document management systems.
