Regulatory Manager / Senior Regulatory Manager (Clinical Trials)

Provides regulatory guidance throughout the clinical development life cycle. Compiles, coordinates and reviews applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards. The role serves as a representative of Global Regulatory Affairs and oversees Regulatory Affairs Specialists to achieve submission targets. Keeps abreast of laws, regulations and guidelines governing drug development and approval.