Regulatory Affairs Officer

6 days ago

Pasig, National Capital Region, Philippines Monroe Consulting Group Full time

Executive Search Firm Monroe Consulting Group is recruiting a Regulatory Affairs – Dossier Specialist on behalf of a regulatory-focused company of a multinational pharmaceutical group. The role is responsible for the preparation, compilation, and organization of regulatory submission documents for domestic and international markets. Working setup is onsite in Ortigas, Pasig City.

Key Responsibilities:

· Assist in the compilation and formatting of product registration dossiers in accordance with ASEAN ACTD, CTD, and other country-specific requirements.

· Coordinate with QA, QC, R&D, and Manufacturing teams to gather technical and supporting documents (formulations, COAs, stability data, etc.).

· Support the preparation of initial registration, renewal, and post-approval variation dossiers.

· Ensure accuracy, consistency, and organization of all documents submitted for review.

· Maintain proper dossier tracking, documentation files, and archives (electronic)

· Assist in responding to regulatory authority queries and in documentation during audits.

· Follow internal Standard Operating Procedures (SOPs) and timelines for submission.

· Continuously learn and stay updated on dossier preparation procedures and regulatory requirements.

Qualifications:

· Licensed Pharmacist

· No prior experience required – fresh graduates are welcome to apply.

· Must be willing to learn, detail-oriented, and able to work under supervision.

· Good organizational and documentation skills.

· Proficient in Microsoft Office applications (Word, Excel, PDF).

· Strong teamwork, communication, and time management skills.

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