Experience

Halloran Consulting Group, Inc.

• United States
• Business Consulting and Services
• 100 - 200 Employee

• Lead Consultant, Regulatory Operations

  • Jan 2021 - Present

  • Manage Regulatory Operations aspects of all Health Authority submissions for Halloran's biotech, pharma, and/or medical device company engagements, including formatting, publishing, Submission planning, Submission management and execution of eCTD Dossiers• Ensure consistent high-quality delivery of client submissions by working collaboratively with internal Halloran team members (regulatory, project management, etc.) and External Clients to ensure projects are delivered on time and within budget• Assist in regulatory project and submission management of cross-functional teams (Clinical Operations, Regulatory Strategists, Regulatory CMC and Quality Assurance) in multiple indications and/or product types across various stages of development; may have client-facing role in this regard• Manage the formatting and publishing of Microsoft Word and PDF documents for submissions to Health Authorities; contribute in hands-on function• External partner and vendor document management - formatting and publishing CROs content (Nonclinical and Clinical Study Reports)• Provide Format and Submission Build QCs of electronic outputs• Oversee the maintenance of tracking tools for regulatory submissions; liaise with Regulatory leads to ensure appropriate planning for submissions• Provide guidance on eCTD publishing standards• Develop reference guides and tools for regulatory submissions• Assess current Halloran systems and take leadership role in proposing and implementing new aspects for regulatory processes and submission management• Provide initial MS Word and Adobe document training to newly hired Halloran team members and/or client teams and remedial training as needed• Manage the creation and maintenance of custom Submission templates, style guides, document libraries, reference guides, and tools for various aspect of document management and submission creation, review, validation, and transmission• Other duties and responsibilities as assigned



Cardinal Health

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Regulatory Scientist II (Reg CMC Product Lead / Strategist)

  • May 2017 - Dec 2020

  • Develop and implement CMC strategies to support pre- and post-approval dossiers.• Perform GAP analysis on legacy product dossiers.• Manage complex projects by shifting priorities across multiple portfolios in order to meet unpredictable and demanding timelines.• CMC Product Lead of regulatory submissions by providing regulatory expertise, strategy planning and coordination discussions with sites, quality assurance, regulatory contacts, and Market Health Agencies.• Prepare, author, review and maintain a variety of global Reg CMC dossiers including, but not limited to Legal Entity Name Changes, align Drug Substance (API) and Drug Product Specification Updates, New market registrations and legacy product regulatory GAP analysis.• Maintain and balance project workloads to ensure timelines are met.• Manage submission readiness, assess manufacturing site changes and regulatory requirements, document legalization, QC, content verification and communicate potential risks.• Open communication with Site and Market Contacts to propose and confirm strategy, filing actions and submission statuses.• Expert in clients network systems (TrackWise, PEARL, PDM and Documentum [GDMS]).



Zoetis Inc.

• United States
• Legal Services
• 1 - 100 Employee

• Reg CMC Senior Associate II (Global CMC Submission Management)

  • Sep 1998 - Apr 2017

  • Manage the execution of Global Reg CMC Submissions for IMPD, IND, IRD, NDA, MAA, BLA, JNDA, pre- and post-approval dossiers per FDA, EMA and Global Health Authorities guidelines and requirements• Authored CMC Annual reports and Renewals for 50+ products• Co-developed Pfizer’s CMC Submission Management (CSM) team• Developed and maintained Module 3/Part II submission templates per FDA and EMA guidelines• Formatted and published pre- and post-approval submissions for the Reg CMC section and prepared US and International submission builds.• Stored, retrieved, and secured files using document lifecycle management within a cloud-based repository and Documentum.• New Hire Trainer - Authoring Templates and use of EDMS• Created and maintained CTD and Part II Templates, the Submission Document Request form, CMC content Submission Ready style guide, Formulated Reg CMC process guides, SOPs and new hire training materials• Submission Document Management Support - Created and maintained the submission document plans and timelines, virtual document (vDoc) builds and maintenance, Quality Check (QC) and format CMC CTD content per our Submission Ready style guide• Collaborate and align Reg CMC Strategy, submission requirements and due dates with content owners.• Host and Support Product/Project kick-off meetings, roundtable and content meetings, content and data reconciliation, maintain content verification and approval workflow• Host Electronic Document Reviews (EDR).• Developed and performed company-wide Instructor led Documentum trainings.• Developed and maintained User Guides/Job Aids on the use of Documentum, SharePoint, Veeva Vault, eCTDXpress, eSubmitter, Authoring within an EDMS (RIM) system, Template use.• Document Management System Change-Over Team - Documentum to Veeva Vault• EDMS Administrator• Traveled to other sites in Pfizer to create templates, train colleagues on systems, and new processes and procedures