Author and lead the development of core regulatory and clinical documents across all programs, including clinical study protocols (Phase 1-3), clinical study reports (ICH E3), investigator''s brochures, regulatory agency briefing documents (FDA Type C/D, EOP2, PreIND), scientific advice packages (e.g., MHRA, EMA), and pediatric plans (PIP/iPSP). Expertise and thorough knowledge of regulatory requirements and technical specifications for the assembly, structure, content, formatting, quality control, and submission of all document types within the CTD process, including management of associated health authority requests.