anna celeste alonzi

Associate Director, Regulatory Affairs CMC

Greater Philadelphia

About

Experienced Senior Regulatory with a demonstrated history of working in the biotechnology industry (oncology, immunology, large and small molecules, vaccines). Skilled in CMC Regulatory Affairs, Supplements, Annual Report, IND/CTA, BLA, MA, cmc, Change Control, Biotechnology, U.S. Food and Drug Administration (FDA), EMA, Global submissions. Corrective and Preventive Action (CAPA). RAPSOnline University: Pharmaceuticals certificate.

Experience

  • Novavax (4 yrs 9 mos)
    • Associate Director
      Dec 2022 - Present · 3 yrs 7 mos

    • Senior Manager, Regulatory Affairs CMC
      Oct 2021 - Present · 4 yrs 9 mos

  • GRA CMC Reg Affairs Associate at Eli Lilly and Company
    Jun 2020 - Oct 2021 · 1 yr 5 mos

  • Sr. Regulatory Associate-Biologics at Genentech
    Feb 2016 - Feb 2020 · 4 yrs 1 mo

    Senior Regulatory Associate in PTR: responsibility for post-approval submissions (AR, CBE-30, PAS, Type I and II) of biologics in compliance with applicable regulations and guidelines. Main activities: Authoring, review and adjudication of regulatory submissions (US, EU, Canada, Japan, RoW) of biologics. Ability to work across the globe with different time zones and global stakeholders. Change control assessor at global level.

  • Volunteer at Vacaville Christian Schools
    Sep 2013 - Jun 2016 · 2 yrs 10 mos

  • Process engineer at Johnson & Johnson
    Oct 2015 - Jan 2016 · 4 mos

    APR/QPR of solids and combination products in Compliance Operation Department.