Norma Olmos
Regulatory Affairs Associate @Navitas Life Sciences
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WORK HISTORY
Regulatory Affairs Associate @Navitas Life Sciences
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
ABOUT NORMA OLMOS
I am an experienced Global Regulatory Affairs Specialist with a proven track record in…
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