Regulatory Affairs - Dossier Specialist

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.