Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Consultant

Key Responsibilities

Global Regulatory Submissions & Lifecycle Management

• Lead the preparation, compilation, review, and submission of regulatory dossiers to global health authorities including US FDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and other international agencies.
• Perform comprehensive dossier gap assessments across CTD Modules 1–5, ensuring completeness, compliance, and submission readiness.
• Author, convert, and manage submissions in eCTD, ACTD, and CTD formats in accordance with regional regulatory requirements.
• Drive end-to-end regulatory submissions for ANDAs, NDAs, BLAs, MAAs, and associated lifecycle activities including variations, renewals, responses, transfers, and withdrawals.
• Coordinate and manage responses to regulatory agency queries by collaborating with CMC, Clinical, Non-Clinical, Quality, and Manufacturing stakeholders.
• Ensure regu...