Pamela Balcazar
McLean,VA
Summary
Regulatory affairs leader with over 15 years of experience advancing oncology and rare disease drug development through global regulatory strategy, FDA submission leadership, and cross-functional program execution. Proven success initiating and directing strategic regulatory initiatives, managing major application packages, and representing the U.S. FDA in critical health authority interactions. Recognized for delivering results with minimal oversight while influencing policy and guidance across internal and external stakeholder networks.
Overview
20
20
years of professional experience
Work History
Sr. Health Scientist
U.S. Food and Drug Administration (FDA)
01.2020 - Current
- Developed and refined regulatory submission strategies for oncology drugs, ensuring compliance with evolving FDA guidelines.
- Oversaw regulatory strategy development and execution, navigating complexities of oncology drug programs to facilitate successful outcomes.
- Collaborated with internal and external stakeholders to create and enforce over 15 comprehensive regulatory guidance documents.
- Engaged with external stakeholders to gather feedback on regulatory frameworks, fostering collaborative relationships to enhance compliance.
- Oversaw agency review initiatives, focusing on real-time oncology review (RTOR) and assessment aid to improve operational efficiency.
- Implemented strategic initiatives within the center to improve the quality and speed of marketing application evaluations to less than 12 months.
- Managed detailed analysis and assessment of over 200 pediatric study plans, ensuring thorough agency-wide review.
- Coordinated and implemented a large-scale reorganization of center operations, ensuring alignment with organizational goals.
- Collaborated with cross-functional teams to create Oncology Center of Excellence, ensuring alignment with FDA objectives and standards.
- Facilitated effective communication between regulatory affairs and clinical development teams to streamline submission processes.
- Coordinated training workshops for staff on regulatory requirements and best practices, enhancing team competency and knowledge.
- Authored and reviewed key regulatory documents, including briefing packages and guidance documents, for accuracy and compliance.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging regulatory review issue
Sr. Regulatory Health Project Manager
U.S. Food and Drug Administration (FDA)
01.2015 - 01.2020
- Facilitated high-level sponsor meetings, offering strategic contributions regarding FDA study timelines, submission pathways, and comprehensive drug development plans.
- Analyzed evolving global regulations to inform and enhance oncology portfolio strategies.
- Coordinated efforts with DIA and industry stakeholders to strengthen public-private partnerships and regulatory engagement.
- Oversaw a team of regulatory project managers, providing mentorship and guidance. Facilitated effective coordination across centers to streamline project execution.
- Directed efforts in policy formulation and offered expert advice on compliance with regulatory standards for new product offerings.
- Led cross-functional teams through all phases of project execution to achieve timely and budget-compliant results. Oversaw project planning and resource allocation to optimize efficiency. Championed continuous improvement practices to elevate project quality.
- Led initiatives to establish oncology guidance frameworks, enhancing treatment pathways within the industry.
- Facilitated end-to-end coordination of sponsor health authority meetings and development of briefing documents to ensure effective communication.
- Engaged with HHS, OMB, and White House to streamline the regulatory guidance clearance process.
Regulatory Project Manager
ACLAIRO Pharmaceutical Development Group
01.2013 - 01.2014
- Authored IND sections, orphan drug applications, and briefing packages.
- Oversaw CRO coordination for nonclinical studies and regulatory compliance.
- Provided strategic regulatory advice to pharma clients and managed submission logistics.
Associate Consultant
PAREXEL Consulting
01.2011 - 01.2013
- Managed regulatory submissions (INDs, NDAs, CTAs) across global markets.
- Directed client engagement, ensured eCTD compliance, and maintained publishing timelines.
Assistant Toxicologist
Covance (now Labcorp Drug Development)
01.2006 - 01.2011
- [Condensed/minimized role as requested]
Education
Master of Science - Regulatory Affairs For Drugs, Biologics And Device
Northeastern University
Boston, MA01-2016
Bachelor of Arts - Biology
George Mason University
Fairfax, VA08-2004
M.C. - Project Management
George Washington University
Washington, DC08-2016
Skills
- Regulatory Strategy & Execution
- Health Authority (Global) Interactions
- Oncology & Rare Disease Programs
- Global Regulatory Intelligence
- Regulatory Policy & Guidance Development
- Business Operations Management
- Matrix Team Leadership & Mentorship
- Submission Planning & Cross-Functional Collaboration
- Process Improvement & Regulatory Innovation
PUBLICATION
Patel TH, Corneli A, Balcazar P, Lipset C, Calvert SB, Mervin-Blake S, Nalawade V, Kluetz PG. Adoption of Decentralized Trial Elements in Cancer Clinical Trials Supporting FDA Approvals during COVID-19. Clin Cancer Res. 2025 May 15;31(10):1827-1830. doi: 10.1158/1078-0432.CCR-24-3357. PMID: 40036170; PMCID: PMC12081193.
Brian Heiss et al. Dosage optimization in drug development: An FDA Project Optimus analysis of postmarketing requirements issued to repair the cracks.. J Clin Oncol 41, 1598-1598(2023). DOI:10.1200/JCO.2023.41.16_suppl.1598
Balcazar, P., et al. FDA Approval: Neratinib for HER2-Positive Breast Cancer. Clin Cancer Res, 2018. DOI: 10.1158/1078-0432.CCR-17-3628
Languages
Spanish
Timeline
Sr. Health Scientist
U.S. Food and Drug Administration (FDA)
01.2020 - Current
Sr. Regulatory Health Project Manager
U.S. Food and Drug Administration (FDA)
01.2015 - 01.2020
Regulatory Project Manager
ACLAIRO Pharmaceutical Development Group
01.2013 - 01.2014
Associate Consultant
PAREXEL Consulting
01.2011 - 01.2013
Assistant Toxicologist
Covance (now Labcorp Drug Development)
01.2006 - 01.2011
Master of Science - Regulatory Affairs For Drugs, Biologics And Device
Northeastern University
Bachelor of Arts - Biology
George Mason University
M.C. - Project Management
George Washington University