Julia Brock
Palm Coast,FL
Summary
Strategic regulatory leader with a strong track record in global regulatory strategy and compliance within oncology. Skilled in project coordination and relationship management, overseeing product lifecycles and securing regulatory approvals in 113 countries. Delivers alignment with international standards to enhance product marketability.
Overview
19
19
years of professional experience
Work History
Director, Regulatory Liaison (RAI HQ) - Oncology
Merck
04.2021 - Current
- Managed product development stages including clinical trial applications (CTAs) in Phase I-III, product registration and launch (PR&L) filings, and post-filing activities, ensuring timely progression through regulatory milestones.
- Manage individuals who develop and implement regulatory strategy to support lifecycle management of In-line products
- Create and drive implementation of the ROW regulatory strategy for their own assigned products
- Collaborated with regional liaisons, country regulatory leads, and other functional areas within global regulatory affairs and clinical safety to align priorities and objectives for ROW filings and lifecycle management activities.
- Review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues
- Conducted regulatory review of product labeling, developed strategy, and released supplementary safety and efficacy supplements to enhance label accuracy and compliance.
- Manage the liaison support process, including resourcing for project assignments, role definition and management of activities for specific products
- Conduct all appropriate HR activities including managing performance, development planning; staffing and related people-management responsibilities for liaisons within areas of responsibility.
- Mentor team members and provide guidance on various aspects of Regulatory Affairs and their projects
- Lead and drive organizational initiatives on behalf of the RAI-HQ Leadership Team and represent RAI-HQ on cross-functional/cross-divisional teams
- Lead and resolve complex quality and compliance issues
- Collaborate and be the point of contact regarding pre-qualification of World Health Organization filings for certain products
Assoc Director, Regulatory Liaison (RAI HQ) - Oncology
Merck
06.2017 - 04.2021
- Provided regulatory input and strategy across all phases of Merck’s development, managing a diverse portfolio of oncology programs to align with corporate objectives.
- Contributed to creation and release of Clinical Trial Applications worldwide, supporting global product strategy to achieve protocol approval for multiple trials.
- Drove international regulatory strategy and operational logistics, ensuring timely registration across Most of World regions to facilitate market access.
- Facilitate the preparation, review, and submission of regulatory documentation and collaborate with subsidiary personnel in liaising with regulatory agencies.
Sr. Scientist, Regulatory Liaison (RAI HQ)
Merck
09.2012 - 06.2017
- Executed the renewal process for product registrations across 113 countries, ensuring compliance with local regulations.- maintain current product licenses for Most of the World - 113 countries
- Obtained Certificate of Pharmaceutical Product and ancillary documents from various sources while managing registration dossier submissions to subsidiaries, ensuring compliance with local regulations.
- Provide regulatory support and guidance to other departments and clients regarding FDA regulations and guidance
- Communicated with international market regional leads to clarify requirements, gather information, and establish critical timelines. Updated project statuses as requested and debriefed project team on market needs. Provided weekly progress reports.
- Review and facilitate signing of documents including Power of Attorney, Letters of Authorization, etc. by internal /external partners and follow by notarization/legalization and shipment
- Monitored and tracked the status of documents throughout the registration process using MOW tracker, SPARC, and RENEWAL database.
- Ensured timely completion and delivery of documents to affiliates before due dates, supporting compliance with regulatory requirements.
- Oversaw the tracking and fulfillment of Health Authority commitments to ensure compliance with regulatory timelines. that are recorded, tracked, and fulfilled in a timely manner
Global Development & Mature Product Liaison, Renewals
Merck
05.2011 - 09.2012
- Independently manage projects, functioning as the sole global point of contact ensuring timely development of appropriate documentation for agency submission
- Reviewed and prepared submission documentation to ensure completeness and accuracy
- Collaborated with subsidiary personnel to streamline renewal process
- Guided teams to achieve regulatory compliance through informed consultation
Clinical Trial Associate/ Study Start Up Management Associate
Exceleron
07.2007 - 04.2011
- Coordinated regulatory submissions and evaluated documents in time-sensitive situations, recommending actions to enhance compliance.
- Developed strategies and progress reports, drafted amendments, and reviewed submission documents to ensure alignment with regulatory standards.
- Obtained, reviewed, and processed regulatory documents, ensuring completeness and currency of all study folders.
- Review and QC Financial Disclosure Forms, 1572, Protocol Documents, Investigator Brochures, CRF’s, Informed Consent, Signature Pages, Medical Licenses and CV’s in addition to any other regulatory documents
- Prepare regulatory binders for each study site as well prepare materials, folders and binders for Investigators’ Meetings
- Submit appropriate paperwork to Internal Review Boards such as WIRB and Quorum. Assist site coordinators who work with local IRB’s
- Maintain study-specific tracking spreadsheets and generate tables and listings from study data
- Managed logistics for drug shipments following site approval.
- Addressed issues and inquiries related to additional study supplies.
Education
Pre-Master’s Certification - Drug Development
Temple University
01-2016
Bachelor of Science - Biology
Montclair State University
05-2000
Skills
- Regulatory submissions
- Regulatory compliance
- Regulatory strategy
- Regulatory project management
- Oncology product strategy
- Strategic leadership
- Critical thinking
- Relationship building
Timeline
Director, Regulatory Liaison (RAI HQ) - Oncology
Merck
04.2021 - Current
Assoc Director, Regulatory Liaison (RAI HQ) - Oncology
Merck
06.2017 - 04.2021
Sr. Scientist, Regulatory Liaison (RAI HQ)
Merck
09.2012 - 06.2017
Global Development & Mature Product Liaison, Renewals
Merck
05.2011 - 09.2012
Clinical Trial Associate/ Study Start Up Management Associate
Exceleron
07.2007 - 04.2011
Pre-Master’s Certification - Drug Development
Temple University
Bachelor of Science - Biology
Montclair State University