Sam Lighting

About Sam Lighting

With over 5+ years of progressive experience in Global Regulatory Affairs at Sanofi, I will now lead Submission Ready Documents operations, providing strategic direction to a team of Electronic Document Specialists in Hyderabad India while ensuring regulatory compliance across R&D documentation. My background includes managing cross-functional teams supporting Regulatory Tracking systems (Vault RIM) and eCTD Publishing platforms, overseeing user experience initiatives, and implementing process optimizations that drive efficiency.My expertise spans CMC documentation authoring, eCTD dossier preparation for global health authorities (FDA, EMA, Health Canada, PMDA), and strategic stakeholder management across R&D functions. I bring strong technical proficiency in regulatory systems including Veeva VaultRIM, Insights Publishing, and various eCTD tools, complemented by a Master\'s in Biotechnology with concentration in Regulatory Affairs from Johns Hopkins University.I excel at leading technology-oriented teams, optimizing document management processes, and ensuring compliance with evolving health authority requirements while delivering cost efficiencies. My combined experience in user support leadership, regulatory operations, and CMC regulatory affairs positions me uniquely to drive excellence in submission-ready documentation and regulatory compliance.

Experience

1. Functional Lead, R & d Submission and Document Services

   Sanofi

   Mar 2025 — Present · Swiftwater, PA, US

Education

• The Johns Hopkins University

  Master's degree, Biotechnology

  2016 — 2018

• Cedar Crest College

  Bachelor of Science - BS, Genetic Engineering

• Cedar Crest College

  Bachelor of Science (BS), Genetic Engineering

  2010 — 2014