Regina P Meeks Email and Phone Number

Support implementation of Restricted Substance Management (RSM), through product stewardship programs to ensure compliance with restricted substance regulations worldwide. • Responsible for maintaining Global Environmental Management System (GEMS) data repository containing product structures and part composition information for REACH, EU RoHS, Packaging, Battery and WEEE directives.• Supports GEMS development and software system release testing Provides direction, clarification and issue resolution for GEMS usage.• Provides direction, clarification and issue resolution for GEMS usage.• Responsible for searching websites to obtain external data for RSM regulations and Emerging Issues for global distribution.• Draft and distribute daily restricted substance regulatory communication • Monitors AbbVie REACH mailbox for incoming customer inquiries.

Support implementation of Restricted Substance Management (RSM), through product stewardship programs to ensure compliance with restricted substance regulations worldwide. • Responsible for maintaining Global Environmental Management System (GEMS) data repository containing product structures and part composition information for REACH, EU RoHS, Packaging, Battery and WEEE directives.• Supports GEMS development and software system release testing and maintains user manual.• Provides direction, clarification and issue resolution for GEMS usage.• Assists in corporate GEMS user training. • Maintains and updates Abbott Chemical Review List (CRL) database referenced by R&D for product development. • Responsible for searching websites to obtain external data for RSM regulations and Emerging Issues for global distribution.• Draft and distribute daily restricted substance regulatory communication and quarterly Chemicals in Review Newsletter.• Monitors Abbott REACH mailbox for incoming customer inquiries.

Support global product distribution, research and manufacturing through maintenance and tracking of Drug Enforcement Administration (DEA) listed chemicals and controlled substance requirements. • Coordinate submissions of corporate-wide DEA registrations and Illinois state controlled Substance licenses for research and analytical testing.• Responsible for the administration of internal DEA databases (Controlled Substance, Power of Attorney (POA), and DEA Records Database) used to communicate DEA information across the corporation and the coordination of related paper and electronic record keeping systems.• Assist with the development and application of global DEA regulatory policies and procedures. • Communicate Fee information to applicable divisional contacts to ensure accuracy and timely payment.• Maintain communication lists for FDA custom detentions and listing/registration issues.• Monitors websites for DEA updates and distributes pertinent information throughout the corporation.• Facilitate annual DEA Coordinator Meeting and provide additional training upon request.

Responsible for intelligence gathering through external website searches and evaluation of significant information for use in management decision making.• Gather and classify external / internal 483s and Warning Letter information for executive analysis.• Responsible for obtaining accurate and applicable external data pertaining to drugs, device and nutritional products and regulations for global distribution.• Responsible for reviewing FDA Enforcement Reports/Warning Letters to prepare monthly metrics report.• Developed a global process to obtain and track FDA Investigator backgrounds and citation history.• Developed procedures and assisted with Documentum Database training for Compendial Tracking.• Developed a tracking mechanism for open Compendial submissions and assured opened issues were addressed or resolved. • Proposed strategy to improve communication/notification process used for global distribution of FDA Med-Watch Reports. • Backup for the DEA Compliance Analyst and Official Correspondent / US Agent responsibilities. • Supported Bio-ethics Committee by updating specifications for Out-Of-Range (OOR) results used for Clinical Studies and maintained training materials for Principle Investigators / Clinical On-Site staff.

Managed staff to support divisions’ record management requests encompassing document record retentions, storage, destruction, and retrieval systems.• Facilitated corporate requirements for archiving, storage, and destruction of records to US and International affiliates.• Implemented and facilitated marketing, educational, record retention and document storage and disposition records management training.• Worked with MIS/Divisional systems development to establish retention schedules for all computer generated data on mainframe systems.• Recommend solutions for large scale paper documentation to be transferred to electronic media to ensure cost effective and efficient usage.• Project Leader for Master Numeric Committee.• Developed and facilitated Laboratory Notebook Training and implemented an audit process for Laboratory Notebooks.• Supervised and trained 2 Records Information Specialist.

Responsible for product registrations and FDA Approval