Falguni Patel

About Falguni Patel

Drug development professional contributing in various roles - Project Management, Regulatory Submission Management, CMC, Clinical and Due Diligence. Effectively works cross-culturally and geographically to successfully manage global programs. Technical and Operational expertise to lead and manage small to medium size drug development programs. Robust Leadership Skills – Interpersonal skills, solid communicator, time management, problem solving skills, adapts well to change, team collaboration. Core Skills - Portfolio analysis, Risk Mitigation and Contingency planning, Business Development and Due Diligence, Budget Management, Life cycle management, Expert in MS Project, Demonstrated Knowledge (FDA, ICH, eCTD, GMP, NDA, IND, EMA, CTA guidances). Achieved the 2004 TAP’s President Award for the submission of alternative administration for SoluTab.

Experience

1. Associate Director, Regulatory Strategic Planning

   AbbVie

   Jan 2017 — Present · North Chicago, IL, US

Education

• University College of Swansea (University of Wales, UK)

  Bachelor's degree, Chemistry with Management Science

  1987 — 1991

• DePaul Driehaus College of Business

  Master of Business Administration (M.B.A.), Marketing Management

  1992 — 1995

Skills

• Business Development
• Drug Development
• Clinical Trials
• Life Sciences
• Planning Budgeting & Forecasting
• Cross-Functional Team Leadership
• Human Resource Planning
• Change Management
• Regulatory Affairs
• Presentation Skills
• Biotechnology
• Ms Project
• Project Management
• Regulatory Requirements
• Pharmaceutical Industry
• Clinical Development
• Fda
• U.s. Food and Drug Administration (Fda)
• Gmp
• Strategy
• Regulatory Submissions
• CRO Management
• Good Clinical Practice (Gcp)
• Program Management
• Team Leadership
• Therapeutic Areas
• Ctms