Doreen V. Morgan

Doreen V. Morgan Email and Phone Number

Vice President Regulatory Affairs @ Anthos Therapeutics a Novartis company
Chatham, NJ, US
Doreen V. Morgan's Location
Chatham, New Jersey, United States, United States
Doreen V. Morgan's Contact Details
About Doreen V. Morgan

As a leader, I am inspired by the future and turning people’s aspirations into reality. I spontaneously look for the good in each individual and their unique qualities and push others to new heights. My word is valuable, and I am hardwired to do exactly what I have committed to. I relish opportunities to share my insights and pinpoint each person’s strengths, motivations, and preferences so they can achieve their dreams and ambitions.Extensive regulatory experience in the health care industry. Expertise includes early and late clinical drug development and commercial launch experience. Delivers both depth and breadth of regulatory knowledge spanning strategic global regulatory affairs, regulatory operations, labeling, publishing, and building strong and effective regulatory teams. Working knowledge of Quality Assurance, Pharmacovigilance and Medical Affairs and the strong cross-functional interdependence with regulatory affairs as a strong competency. Led and participated as a key strategic stakeholder in numerous FDA Advisory Committee meetings across multiple therapeutic areas including CDER and CBER.Specialties: Strong Strategic Global Regulatory Partner; FDA Advisory Committee Meetings expertise; Small/Large Molecules, Cell and Gene Therapy Drug Development; Promotion and labeling review; Global NDA/BLA submission and approvals; Quality Assurance-cGCPS; Talent recruitment -building and retaining effective regulatory teams; Partnered with Academic Institution to create PharmD Fellowships in three Pharma/Biotech companies.

Doreen V. Morgan's Current Company Details
Anthos Therapeutics a Novartis company

Anthos Therapeutics A Novartis Company

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Vice President Regulatory Affairs
Chatham, NJ, US
Doreen V. Morgan Work Experience Details
  • Anthos Therapeutics A Novartis Company
    Vice President Regulatory Affairs
    Anthos Therapeutics A Novartis Company
    Chatham, Nj, Us
  • Anthos Therapeutics
    Vice President Regulatory Affairs
    Anthos Therapeutics Oct 2024 - Present
    Cambridge, Massachusetts, Us
    View
  • Self-Employed
    Independent Consultant
    Self-Employed Jan 2024 - Oct 2024
    Regulatory consulting on all phases of clinical drug development, with an emphasis on submission strategy and risk mitigations.
  • Ptc Therapeutics, Inc.
    Vice President, Head Of Global Regulatory Stratgy
    Ptc Therapeutics, Inc. Sep 2021 - Jan 2024
    Us
    View
  • Mesoblast Limited
    Vp Global Regulatory
    Mesoblast Limited 2020 - Sep 2021
    Melbourne, Vic, Au
    Global VP of Regulatory Affairs
    View
  • Leo Pharma
    Vice President Us Regulatory Affairs & Qa
    Leo Pharma Nov 2017 - 2019
    Ballerup, Dk, Dk
    View
  • Leo Pharma
    Vice President Of Us Regulatory Affairs
    Leo Pharma 2015 - 2017
    Ballerup, Dk, Dk
    View
  • Daiichi Sankyo
    Executive Director, Regulatory Affairs
    Daiichi Sankyo Jan 2007 - Oct 2015
    Basking Ridge, Nj, Us
    View
  • Forest Research Institute
    Sr. Director Of Regulatory Affairs
    Forest Research Institute 2001 - 2007
  • Knoll Pharmaceuticals
    Director Regulatory Affairs
    Knoll Pharmaceuticals 1996 - 2001
    East Greenville, Pennsylvania, Us
    View
  • Hoffman La Roche
    Manager Regulatory Affairs
    Hoffman La Roche 1993 - 1996

Doreen V. Morgan Skills

Regulatory Affairs Drug Development Clinical Development Clinical Trials Regulatory Submissions Pharmaceutical Industry Nda Ind Gcp Drug Safety Cro Fda Pharmacovigilance Medical Affairs Regulatory Requirements Pharmaceutics Ectd Biopharmaceuticals Medical Writing Ctms Oncology Sop Therapeutic Areas 21 Cfr Part 11 Pharmacology Gxp Glp Good Clinical Practice New Drug Application U.s. Food And Drug Administration Electronic Common Technical Document Standard Operating Procedure Cmc Pharmacokinetics Clinical Trial Management System Cro Management Clinical Pharmacology Biologics Good Laboratory Practice

Doreen V. Morgan Education Details

  • St. John'S University
    St. John'S University
    Pharmacy

Frequently Asked Questions about Doreen V. Morgan

What company does Doreen V. Morgan work for?

Doreen V. Morgan works for Anthos Therapeutics A Novartis Company

What is Doreen V. Morgan's role at the current company?

Doreen V. Morgan's current role is Vice President Regulatory Affairs.

What is Doreen V. Morgan's email address?

Doreen V. Morgan's email address is dn****@****rma.com

What is Doreen V. Morgan's direct phone number?

Doreen V. Morgan's direct phone number is +197363*****

What schools did Doreen V. Morgan attend?

Doreen V. Morgan attended St. John's University.

What skills is Doreen V. Morgan known for?

Doreen V. Morgan has skills like Regulatory Affairs, Drug Development, Clinical Development, Clinical Trials, Regulatory Submissions, Pharmaceutical Industry, Nda, Ind, Gcp, Drug Safety, Cro, Fda.

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