Norma Olmos

About Norma Olmos

I am an experienced Global Regulatory Affairs Specialist with a proven track record in…

Experience

1. Regulatory Affairs Associate

   Navitas Life Sciences

   Aug 2023 — Present

   Manage end-to-end regulatory submissions across US, Canada, and EUIncluding INDs, NDAs, ANDAs, BLAs, DMFs, CMC lifecycle submissions (PAS, CBE-30, CBE-0), labeling updates, and advertising/promotional materials.Support therapeutic portfolios including oncology, internal medicine, vaccines, hospital brands, and sterile injectables.Provide publishing support for global submissions in LATAM, Asia, and AFME Compile, publish, and dispatch high-quality, compliant regulatory dossiers using Citrix-based tools (GDMS, PEARL, Lorenz eValidator, FDA ESG, Rosetta Phoenix, Compass, CESP).Independently support and track submission timelines, ensuring on-time delivery to FDA, Health Canada, and EMA in line with SOPs and KPIs.Collaborate cross-functionally to resolve submission issues, maintain regulatory compliance, and implement best practices.Contributed to regulatory strategy discussions by providing historical context and assessing implications of evolving guidelines (FDA, ICH).Assisted in the development of improved SOPs and submission management systems, enhancing team efficiency and compliance

Education

• Keck Graduate Institute

  Post-baccalaureate Applied Life Sciences Certificate (1 year program)

• The University of Texas at Arlington

  Bachelors of Science

Skills

• Teamwork
• Microsoft Excel
• Powerpoint
• Public Speaking
• Microsoft Word
• Customer Service
• Microsoft Office