Nancysabel Garcia
About Nancysabel Garcia
Nancysabel Garcia is the Director of Regulatory Affairs for New Markets at Beigene, with extensive experience in pharmaceutical regulatory affairs and a background in pharmacy.
Current Role at Beigene
Nancysabel Garcia currently holds the position of Director of Regulatory Affairs for New Markets at Beigene in Northbrook, IL. In this role, she provides comprehensive regulatory support and ensures compliance with global standards for pharmaceutical products. Her responsibilities include overseeing new market entries, coordinating with regulatory authorities, and ensuring that all regulatory documentation meets the required guidelines.
Previous Experience at HireGenics and Abbott Molecular Diagnostics
Before joining Beigene, Nancysabel Garcia worked at HireGenics from 2020 to 2021, where she was assigned to Abbott Molecular Diagnostics - Global Regulatory Affairs. During her tenure, she contributed to the global regulatory strategies and supported product lifecycle management. Her role involved collaboration with global teams to ensure regulatory compliance and successful product registrations.
Career at Astellas Pharma US
Nancysabel Garcia served as the Director of Regulatory Affairs at Astellas Pharma US from 2015 to 2019. Based in Northbrook, Illinois, she was responsible for leading regulatory strategies, ensuring product compliance, and managing relationships with regulatory authorities. Her work involved guiding product development, managing quality assurance, and overseeing regulatory submissions. Additionally, she played a key role in mentoring junior staff and fostering collaboration among the regulatory teams.
Founder and Principal at NGM Office LLC
From 2009 to 2015, Nancysabel Garcia founded and led NGM Office LLC in Weston, Florida. As the Founder and Principal, she provided consultancy services specializing in regulatory affairs. Her responsibilities included strategic planning, regulatory compliance, and business development. She also built and maintained relationships with regulatory agencies and commercial leaders, ensuring the successful navigation of complex regulatory landscapes.
Early Career at Janssen Inc. and Venezuelan Ministry of Health
Nancysabel Garcia began her career as a Pharmacist at the Venezuelan Ministry of Health from 1987 to 1991 in Caracas, Venezuela. She then worked at Janssen Inc. as Regulatory Affairs Director from 1991 to 2009. In these roles, she gained extensive experience in regulatory systems, compliance standards, and international business. Her work involved pharmacovigilance, risk management, and ensuring adherence to GxP, GMP, GLP, and GCP standards.
Educational Background
Nancysabel Garcia earned her B.S. in Pharmacy from Universidad 'Santa María'. Her educational background laid a strong foundation for her extensive career in regulatory affairs and pharmaceutical sciences. This academic training has equipped her with the necessary skills and knowledge to navigate complex regulatory requirements and contribute effectively to the pharmaceutical industry.