Tabetha M. Bonacci

Head of LCM and Site Regulatory

Co-lead for the lifecycle management CMC regulatory group. Manage a team of global product leads and associates responsible for RA-CMC activities for 50% of Amgen's commercial portfolio. Advise on regulatory strategy and review regulatory filings for post-approval variations. Responsible for developing processes and tools for effective compilation of post-approval supplements. Analyze and adapt regulatory strategies for post-approval trends. Comment on regulatory guidences impacting marketed products. Departmental representation on cross-functional project teams and select governance bodies. Key external initiative lead for post-approval change management.

RA-CMC global product lead for multiple commercial biological therapeutics. Member of global regulatory and global operations teams responsible for developing global regulatory strategy for post approval CMC changes. Managed between 2- 4 commercial products leading regulatory supplements resulting in first-cycle approval of: drug substance manufacturing site changes, drug product manufacturing site changes, transfer of analytical methods, drug substance and drug product process changes, and a new drug product SKU.

5/2013-2/2015: Global Product Lead RA-CMC lead for a commercial biologic. Member of global regulatory and global operations teams responsible for developing global regulatory strategy for post approval CMC changes including manufacturing process changes, changes to control strategy, second source syringe supplier and design improvements to an auto-injector. 10/2011-4/2013: Site Regulatory Responsible for regulatory activities at a commercial drug substance manufacturing site including, change control regulatory support for non-conformances, CAPAs, risk assessments, and new product introductions. Served as the Annual Report Coordinator, coordinating efforts for commercial products, streamlining the process to reduce redundancies and drafting of manuals. Provide support to Global CMC product leads for site-specific regulatory submissions

Product quality reviewer for pre-INDs, INDs, IND amendments and clinical INDs across multiple therapeutic disciplines. Responsible for participating in FDA-Sponsor meetings, including pre-IND meetings, end-of-phase II and pre-BLA meetings. Perform lab-based research on adhesive molecules in breast cancer