Holly Davidson Email and Phone Number

• Knowledge of worldwide regulatory requirements for intial filings, re-registration, regional business deals and post-approval changes• Authors and maintains portions of the chemical and manufacturing and control (CMC) document for registration worldwide• Prepared global registration renewals, global supplements and variations and global responses to health authority questions• Provides regulatory assessments on process change controls• Familiar with several CMC systems such as living document repository, GMP release system, and change control tracking systems• Manages multiple deadline driven planned and unplanned projects to deliver on time and right the first time.• Familiar with pharmaceutical solid oral dosage forms• Sits on several project teams for Regional Business Deals, mostly in Eastern Europe, Middle East and Africa (EEMEA). Began work on some Latin American and Asia Pacific deals. • Works as part of a team to complete compliance and strategic projects.

• Manufactured vaccines along with alum diluent and several buffers according to batch records in a GMP environment• Followed Good Manufacturing Practices, SOPs, quality procedures, safety, and environmental standards. • Effective in troubleshooting several different issues within the production environment. • Able to maintain precise documentation of processes.