Regulatory Affairs Specialist –

Key Responsibilities :

Regulatory Submissions & Compliance

• Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.
• Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).
• Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTD.
• Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals).
• Coordinate responses to health authority queries through cross-functional collaboration and data collation.
• Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions.

Project Planning & Management

Requirements :