Sean O'Bryan

Sean O'Bryan Email and Phone Number

Uber rating 4.89. Seasoned biologics consulting toward commercial approval - offering "smart strategy" for the shortest distance between point A and B. @ Sonoma Biotherapeutics
Sean O'Bryan's Location
Cambridge, Massachusetts, United States, United States
Sean O'Bryan's Contact Details

Sean O'Bryan personal email

n/a
About Sean O'Bryan

Industry professional with over 30 years of comprehensive global Regulatory Affairs and Quality experience focused on leading regulatory and compliance strategy and overall product development from early stage to commercialization, predominantly in the field of novel biologics including vector-based gene therapies, cell therapy including CAR T and regenerative medicine.

Sean O'Bryan's Current Company Details
Sonoma Biotherapeutics

Sonoma Biotherapeutics

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Uber rating 4.89. Seasoned biologics consulting toward commercial approval - offering "smart strategy" for the shortest distance between point A and B.
Sean O'Bryan Work Experience Details
  • Sonoma Biotherapeutics
    Svp, Head Of Regulatory Affairs
    Sonoma Biotherapeutics Aug 2023 - Present
    South San Francisco, California, Us
  • Accelerated Biologics Consulting
    Founder & Chief Consultant
    Accelerated Biologics Consulting Jan 2022 - Present
    Cambridge, Massachusetts, Us
    30 years of building start up companies and teams with a successful track record. A focus on Acting Interim Head of Regulatory, regulatory strategy, clinical strategy, reg CMC, and project leadership in the regenerative medicine and immunotherapy space.
  • Freeline
    Svp, Global Head Of Regulatory Affairs
    Freeline Nov 2020 - Jan 2022
    Stevenage, England, Gb
  • Axovant Sciences, Inc.
    Svp, Regulatory Affairs & Quality Assurance
    Axovant Sciences, Inc. Dec 2018 - Nov 2020
  • Lysogene
    Vp, Regulatory Affairs And Quality Assurance
    Lysogene Jan 2016 - Dec 2018
  • Bluebird Bio
    Sr. Director, Regulatory Affairs
    Bluebird Bio Aug 2014 - Oct 2015
    Somerville, Massachusetts, Us
    Regulatory Strategy Regulatory CMC head
  • Sanofi Genzyme
    Director, Regulatory Affairs
    Sanofi Genzyme Apr 2006 - Aug 2014
    Paris, France, Fr
    Product RA Head for Cell Therapy and Regenerative MedicineBLA, MAA, IND, IDE, CTASeasoned with FDA - CDRH & CBER, EMA, Health CanadaRA Lead on groundbreaking Regulatory framework in China for Biologics

Sean O'Bryan Skills

Biotechnology Regulatory Affairs Bla Fda 21 Cfr Part 11 Ema Atmp Ctas Maa Ide Ind Paediatric Requirements Panel Meetings Lifesciences Gmp Orphan Drugs Sop Glp Validation Capa Technology Transfer Regulatory Submissions Pharmaceutical Industry Change Control Medical Devices Medical Device R&d Medical Device Directive Combination Products Life Sciences

Sean O'Bryan Education Details

  • Boston University
    Boston University
    Environmental Science & Policy

Frequently Asked Questions about Sean O'Bryan

What company does Sean O'Bryan work for?

Sean O'Bryan works for Sonoma Biotherapeutics

What is Sean O'Bryan's role at the current company?

Sean O'Bryan's current role is Uber rating 4.89. Seasoned biologics consulting toward commercial approval - offering "smart strategy" for the shortest distance between point A and B..

What is Sean O'Bryan's email address?

Sean O'Bryan's email address is se****@****ant.com

What schools did Sean O'Bryan attend?

Sean O'Bryan attended Boston University.

What skills is Sean O'Bryan known for?

Sean O'Bryan has skills like Biotechnology, Regulatory Affairs, Bla, Fda, 21 Cfr Part 11, Ema, Atmp, Ctas, Maa, Ide, Ind, Paediatric Requirements.

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