Fourteen Years and ten months working experience in in the development of Regulatory Strategy, CMC authoring, Regulatory intelligence, Regulatory filings & Project management.• CMC regulatory matters relating to registrations and life-cycle management of business activities (including variations and renewals) for small molecule.• Regulatory guidance on regulatory requirements for small molecule marketing applications, and lifecycle changes to marketed products.• Manage CMC submissions, ensuring thoroughness, completeness, and timeliness.