Chemistry, Manufacturing and Controls (CMC): - Direct liaison to the FDA.- Product principal for Medicated feed additive and companion animal products. Interface with Clinical Development, Operations, Supply Chain, and Quality colleagues. Provide expert recommendations and decisions on regulatory issues relating to CMC, including proactive risk management and mitigation.- Responsible for the development and maintenance of CMC registrations for a product portfolio that includes: New Animal Drug Applications (NADAs), Abbreviated New Animal Drug Applications (ANADAs), Investigational New Animal Drugs (INAD) and Generic Investigational New Animal Drugs (JINAD).- API and manufacturing site changes.- Application of strategic regulatory expertise to achieve organizational lean manufacturing goals.- De facto project manager on multiple projects.- Author/approve CMC-related INAD amendments, NADA supplements and MCSRs.- VMF authoring and updating. Major Accomplishments: Smooth integration of the Alpharma product portfolio into Pfizer, Inc. regulatory systems and applications – U.S. and Latin America – December 2012.Management:- Daily management of the regulatory change control management system. 2 direct reports – October 2014 – November 2017.Major Accomplishments: - Successful launch of a new regulatory change control management system 1 month prior to deadline – May 2015. - On time delivery of Version 2 of Regulatory Change Management system – February 2016.Pre-Approval Projects:- Primary regulatory contact for fixed combination and generic projects.

Manager, Regulatory AffairsU.S.- Project Management – RA lead on all U.S. development projects. Responsible for the creation of and adherence to MS Project timelines. - Product Development - preparation and submission of NADAs, ANADAs, JINAD, and INAD files.Major Accomplishments: 2 new product approvals (NADA), Technical Section Complete letters for 2 projects – efficacy, environmental safety. Regulatory management of multi-location (7) efficacy study submission.International- Management of the planning, priority, and implementation of regulatory activities in the Latin America region (16 countries).- New product registrations. Post market support - registration license renewal. - CMC - sourcing/manufacturing site changes, product formulation revisions. Major Accomplishments: Spearheaded initiative to remediate 3 product registrations in Brazil. Project began 2/10, first product returned to market 1/11. Product registrations: 12 geographic expansions, 1 new product indication, 3 new products (Mexico).- Supervision and training of department staff members (2).- Participation in two Animal Health Institute (AHI) Working Groups – Labeling, Food Animal Review Cycle Team.- Participation in one FDA pilot project – SEND (electronic submission of safety and effectiveness data).

Executive Account Manager  Business-to-business selling. Identification and prospecting of target markets/industries. Customized client presentations. Database creation and management. Vendor relations, market research, creation of customized presentations and proposals.Accomplishments: Increased territory client base by 150% and revenues by 67% between June 2002 and May 2003.

Creation of marketing and promotional materials including CD-ROMs, brochures and catalogs. Development and administration of promotional programs for customers. Daily management of cooperative advertising program (1990 - 2002). Customer training and development - on-site, sales meetings, etc. Began career with the company in 1989. Promoted 3 times to final position as the Manager of Dealer Business Building programs.