Marie Murtagh, RAC, PMP

Director, Regulatory Systems, Operations and Promotion at Pacira BioSciences, Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
Fort Lee, New Jersey, United States, JE

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Robyn Pier

Marie is extremely knowledgeable in her role. She is a great team member and is always going above and beyond to help her fellow co-workers. Many times Marie took time out of her busy schedule to help me with a project I was working on. It was always a pleasure to work with Marie! Everyone at Pacira is very lucky to have her role as Associate Director. Thanks for everything Marie!

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Credentials

  • Asserting Yourself, an Empowered Choice
    LinkedIn
    Mar, 2020
    - Nov, 2024
  • Learning to Be Assertive
    LinkedIn
    Oct, 2019
    - Nov, 2024
  • RAC-US
    Regulatory Affairs Certification Program
    Nov, 2010
    - Nov, 2024
  • Project Management Professional (PMP)
    Project Management Institute
    Sep, 2021
    - Nov, 2024

Experience

  • Pacira BioSciences, Inc.
    • United States
    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • Director, Regulatory Systems, Operations and Promotion
      • Jan 2022 - Present

      • Member of the Regulatory Leadership Team (RLT)• Provide strong leadership with IT and Regulatory business process expertise to drive the ongoing transformation and continuous improvement within RA. • Ensure Reg Information tools and systems are implemented, validated, and maintained in accordance with company SOPs and applicable regulations. • Spearheaded training and video content to ensure seamless onboarding of team members.• Responsible for all submissions to be error free from a regulatory validation standpoint and are submitted on time to meet any internal or external requirements. • Responsible and accountable for implementing SOPs and work processes for publishing, submissions, and archiving.• Manage tracking and timely archiving of regulatory submissions and communications. • Identify, assess risks that can impact submissions and mitigate those. • Drive continuous process improvement through leadership of initiatives to capture learnings, identify opportunities for change and in partnership with global peers, develop a change management plan for implementation. • Partner with peers to increase visibility of upcoming submissions and deliverables across the regions. • Participate in the definition of requirements and evaluation of technologies and support system implementation as appropriate. • Assist with the development and implementation of standards for dossier management, publishing, archiving, metrics, and submission process for global health authorities. • Manage vendors and contractors as applicable to systems and technology project(s).• Oversee the development and execution of regulatory strategies and processes as it relates to advertising and promotional materials.• Oversee all aspects of Ad-Promo interactions with PCRC regulatory reviewers as appropriate to ensure successful review and approval of advertising and promotional materials.• Plan and manage regulatory submissions related to advertising and promotional materials. Show less

    • Associate Director, Regulatory Compliance
      • Jan 2019 - Jan 2022

      • Acts as the chair of the Public Communications Review Committee (PCRC) for Pacira products marketed in the US; reviews materials for conformance with FDA regulations and guidance.• Monitors and maintains awareness of the US regulatory and legal environment, particularly with respect to advertising and promotional review of pharmaceuticals and other medical products; assesses impact to business; interprets and disseminates information to affected departments across the company.• Responsible for administration of the Veeva Vault System, where all PCRC materials are reviewed, approved, and archived.• Ensures FDA 2253 submissions are executed and are of high quality and on-time.• Maintains and updates PCRC and other related SOPs; prepares and conducts training on SOPs where applicable.• Responsible for process standards, planning, publishing, production, dispatch, and archive of regulatory submissions.• Demonstrates expert Regulatory publishing skills, a general proficiency in Process Excellence and planning, and expert working knowledge of electronic document management practices and related technologies. Show less

    • Senior Manager Regulatory Affairs
      • May 2017 - Jan 2019

      I was hired to manage the PCRC System and launch the division.

  • Phibro Animal Health
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Associate Manager Regulatory Affairs
      • Jun 2014 - Mar 2017

      • Update the Global Registration Database making sure the information is current and accurate. Prepare report of current registrations for the 10K financial report. • Compile, review and maintain international dossiers. • Review, comment and/or approve (international and US) marketing materials. • Yearly Feed Additive Compendium review and reconciliation • ADUFA Fee Reconciliation • Process Certificate of Quality for Supply Chain monthly or as provided. • Update the Global Registration Database making sure the information is current and accurate. Prepare report of current registrations for the 10K financial report. • Compile, review and maintain international dossiers. • Review, comment and/or approve (international and US) marketing materials. • Yearly Feed Additive Compendium review and reconciliation • ADUFA Fee Reconciliation • Process Certificate of Quality for Supply Chain monthly or as provided.

  • Par Pharmaceutical
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Manager, Regulatory Operations
      • Feb 2010 - May 2014

      • Independently track, assemble, publish, and dispatch NDA/ANDA regulatory submissions, including both major applications and amendments/updates to existing regulatory applications. • Review CRC materials. Monitor warning letters - OPDP and send communication to the team summarizing activity. • Responsible (assigned products) for all aspects of publishing submissions for internal review and signoff and for submission to regulatory authorities. This includes operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, production (paper and electronic), and archiving (paper and electronic), as applicable. Show less

  • Eisai US
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Regulatory Associate
      • Oct 2004 - Jan 2010

      • Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, production (paper and electronic), and archiving (paper and electronic), as applicable. • Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, production (paper and electronic), and archiving (paper and electronic), as applicable.

Education

  • Cornell University
    Certificate in Women in Leadership, Leadership
    2023 - 2023
  • Saint Peter's University
    BS, Business Management
    1986 - 1990

Community

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