Scott Graves Email & Phone Number

O'Fallon, Mo, Us

Greater St. Louis Area

Responsible for managing and coordinating both internal and external personnel who play a key role in driving efficient Global Chemistry, Manufacturing, and Controls (GCMC) regulatory submission publishing across product portfolio, including products with Fast Track designation. Maintain information related to product submission tracking timelines, requirements, and documentation. Working closely with other cross functional teams and stakeholders, including CMC Product Strategists, CMC… Show more Responsible for managing and coordinating both internal and external personnel who play a key role in driving efficient Global Chemistry, Manufacturing, and Controls (GCMC) regulatory submission publishing across product portfolio, including products with Fast Track designation. Maintain information related to product submission tracking timelines, requirements, and documentation. Working closely with other cross functional teams and stakeholders, including CMC Product Strategists, CMC Regional Strategist, Global Regulatory Operations, and Global Supply. Ultimately accountable for ensuring that submission-ready documents are executed and delivered according to timelines and procedures. Analyze and optimize data systems, ensuring compliance and efficiency in submission processes which maximize operational effectiveness. Maintain CMC product information, market specific submission details, and component level dossier content utilizing an integrated change management process which provides a comprehensive view of product market compliance. Member of Acquisitions Collaborations and Divestitures Team responsible for migration for CMC dossiers and content into Pfizer systems to enable transition of licenses and registrations. Successfully transitioned products associated with more than 7 major acquisitions.Onboard, trained, and managed external vendors as a cost savings support model in multiple geographical locations including China, Ireland, India, and US. Change Advisory board member for Clinical and Commercial change management processes. Provide solutions and understanding to issues and strategies for managing the CMC regulatory change management submission processes and systems.Accumulus Implementation team member evaluating impact on the business units and decisions on participation/investment in 2024 pilot. Show less

Missouri, United States

Managed internal and external team responsible for maintaining Global CMC product information, market registration details, component level dossier content, and an integrated change management process to support compliance with the CMC registered details of all products in all markets. Coordinated personnel and activities related to the preparation, review, distribution, and archival of Electronic Common Technical Documents (eCTD), as well as regional paper-based formats.