Manage regional regulatory activities for assigned IND and NDA projects. Serve as company liaison with FDA. Implement regulatory strategy and achieve regulatory readiness with other line functions.Represent DRA on various project and medical teams. Lead sub-teams as required.Facilitate timely submissions and approvals while adhering to regulatory requirements

Supported Managers to achieve planned IND/NDA submissions for Phase 1- IV projects Prepared various electronic submissions including Briefing Books, Original IND/NDA's, Product labeling documents, Risk Management Plans, Annual Reports, Response to FDA Requests, and Complete Response Documents Ensured regulatory and eCTD technical file requirements are met. Developed and expanded regulatory knowledge beyond current role including:Advisory Committee Meeting preparation. Frequent collaborations with logistics and project support vendors. Coordinated various aspects of rehearsal meeting's including obtaining external HCP consultants DRA representative on Regional Distribution Set-Up of Clinical Supplies Workstream

Supported various Phase I and Phase II Drug Substance CampaignsResponsible for analytical methods development, early phase batch release, method validation, and stability testing to support raw materials, intermediates, and synthetic drug substances in a GMP environment.Authored analytical product specifications, test methods, stability protocols, and impurity profile reports.Managed two laboratories including ordering all chemicals and supplies. Served as department liaison with instrument vendors.Demonstrated increasing levels of responsibility, promoted March 2008.