Norma Schafer, MS, RAC

VP, Regulatory Affairs

Norma has been working in the field of Regulatory Affairs for over 35 years. During that time, she has participated in the research, development and launch of prescription pharmaceuticals, medical devices, and over-the-counter products. Her career path has led her to work with several excellent companies including Abbott Laboratories, Alcon Laboratories/Novartis, ZS Pharma/AstraZeneca, SteadMed Medical/Urgo and Tecnol Medical Products/Kimberly Clark.

Norma earned a degree in Medical Technology from Baylor University Medical Center and a Master’s Degree in Regulatory Affairs from San Diego State University. She has continued to support the San Diego State program as an instructor where she teaches across the spectrum of Regulatory Affairs topics.

Norma applied her Regulatory Affairs skills in planning, management and support of entire product lines from cradle to grave. She has led submission management for eCTD submissions worldwide (primarily focusing on the US, EU, Canada, Australia and China) as a member of the Regulatory Ops team. As part of Regulatory Strategy team, she worked closely with sub-teams in marketing, reimbursement, shipping, clinical, chemistry, manufacturing and controls to support, advise and ensure regulatory compliance.

Prior to joining Renibus, Norma was VP of Regulatory Affairs and Quality Control at SteadMed Medical, Director of Regulatory Affairs at ZS Pharma and Director of Regulatory Affairs at Alcon Laboratories.

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