Rachel Summers

Senior Regulatory Operations Manager at Ground Zero Pharmaceuticals

Rachel Summers has worked in the professional field since 2000. Rachel began their career at Cohen Financial Services as the Director of First Impressions, where they assisted three brokers in daily client financial activities and online trading of stocks. Rachel also created monthly, quarterly, and year-end financial reports, and organized a filing system for a client base of more than 1,000 people. In 2004, Rachel moved to Access Advertising as a Senior Sales Executive. There, they built and maintained professional relationships with over 200 local and national clients, and generated over $1 million in revenue via phone sales. In 2012, Rachel joined Cardinal Health as a Specialist I, Regulatory Submission Operations-Publishing. In this role, they managed large NDA, IND, ANDA, NDS, MAA, NeeS, and CEP submissions, and assessed submission content and made recommendations to meet agency guidance standards. Rachel also developed and led group training for new and current employees on processes, procedures, and regulatory requirements. Rachel was promoted to Lead Coordinator in 2014, and Senior Coordinator in 2015. In 2018, Rachel moved to Ground Zero Pharmaceuticals as a Senior Regulatory Operations Manager. In this role, they were accountable for managing Pre-NDA, NDA, Pre-IND, and IND submissions, and dedicated to providing technical guidance for eCTD compliance, life cycle management, and agency approval. Rachel also performed final quality reviews of Clinical Study Reports from medical writing staff.

Rachel Summers received their Associate of Arts degree from Johnson County Community College in 2002, having studied Liberal Arts from 1998 to 2002. Rachel then went on to receive their Bachelor of Science in Business Administration from the University of Missouri-Kansas City in 2004.

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