Regulatory Affairs

Regulatory Affairs CTD / eCTD Dossier Preparation ANDA / NDA Product Registration Global Regulatory Submissions Injectable Products (if applicable) Lifecycle Management Regulatory Compliance Labeling Review Variation & Renewal Submissions Health Authority Queries Change Control GMP Compliance ICH Guidelines USFDA / EMA / MHRA / WHO / TGA (as applicable) Documentation Management Cross-functional Coordination Regulatory Intelligence SOP Preparation & Review CMC Documentation Artwork Review Submission Tracking Technical Writing Project Management Good Communication Skills