Summary
Overview
Work History
Education
Skills
Certification
Affiliations
Timeline
Generic

Joseph Onyeizu

Willow Grove,PA

Summary

Highly motivated, personable global health professional with two Master of Science degrees and an MBA. Currently supporting healthcare companies as a subject matter expert in Quality Systems. Experienced Regulatory Affairs Consultant and Director with extensive expertise in oncology, vaccines, and infectious diseases. Proven track record in leading regulatory submissions, strategic planning, and global regulatory strategies for both U.S. and international markets. Strong understanding of complex regulatory environments and international health regulations. Skilled in driving cross-functional collaboration and ensuring compliance with regulatory requirements throughout the product lifecycle, from early-stage development to post-market activities.

Determined and well-rounded individual with more than 17 years working as Scientist within Pharmaceutical/Biotech industry. Sharp and focused professional offering skills in regulatory science and medical affairs.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Senior Scientist, Regulatory Affairs – Oncology & Biologics

Merck
10.2021 - Current
  • Led preparation and submission of INDs, BLAs, CTAs, and NDAs for oncology therapies, vaccines, and novel biologics, managing the full lifecycle of regulatory filings.
  • Acted as primary liaison with regulatory authorities, facilitating discussions and responding to inquiries about submissions, clinical trial data, and post-marketing surveillance.
  • Developed global regulatory strategies for early-stage oncology and vaccine products, ensuring alignment with local regulatory requirements.
  • Advised on post-market surveillance and regulatory reporting requirements, including periodic safety update reports (PSURs) and annual reports.

Senior Scientist, Regulatory Affairs – Oncology & Biologics

Harvard Medical School - Harvard Innovation Labs - Merck
01.2021 - 05.2023
  • Designed clinical service line optimizations and co-founded a triaged clinical service line.
  • Created a digital platform for clinical label information, eliminating the need for traditional leaflets.
  • Led patient advocacy and strategic regulatory guidance for oncology, vaccine, and infectious disease products, ensuring global compliance with regulatory frameworks across the U.S., EU, and other international markets.

Senior Scientist, Regulatory Affairs – Oncology & Biologics

Merck & Co.
01.2021 - 01.2022
  • Directed regulatory strategies for the oncology pipeline and infectious disease portfolio, overseeing U.S. and international regulatory submissions and approvals.
  • Coordinated submission of NDA/BLA filings, INDs, and CTAs for oncology and vaccine programs across multiple markets (U.S., EU, Japan, China).
  • Managed interactions with FDA, EMA, TGA, and PMDA, ensuring feedback and regulatory requirements were integrated into development plans.
  • Played a key role in obtaining accelerated approval and orphan drug status for oncology therapies, reducing time to market.
  • Supported agency interactions, including responses to regulatory queries, Pre-Submission Meetings (PSMs), and FDA communications.
  • Developed regulatory policies and procedures, ensuring compliance with global regulations, including the preparation and submission of Annual Reports (ARs) and Development Safety Update Reports (DSURs).

Manager, Quality Control - Vaccine Global Operations

Merck & Co.
01.2019 - 01.2021
  • Supervised a team of eighteen, overseeing assays for Tissue Culture and Egg Safety Testing.
  • Served as Subject Matter Expert (SME) in analytical techniques, providing technical assistance to Merck Manufacturing and support departments.
  • Coordinated and participated in regulatory audits, ensuring GMP and GLP compliance for in vivo and in vitro testing.

Laboratory Biotechnologist – Vaccine Laboratory Operations

Merck & Co.
01.2008 - 01.2012
  • Applied Lean Six Sigma concepts to consolidate processes across multiple locations, reducing the footprint required for varicella potency testing.
  • Managed data input using LIMS, Microsoft Excel, and controlled GMP worksheets, with extensive experience in plaque assays for vaccine testing.

Research Associate, siRNA In Vivo Delivery Biology Team Member

Merck & Co.
01.2007 - 01.2008
  • Gained hands-on training in RNAi therapeutics and in vivo delivery biology of siRNA molecules for cancer and genetic diseases.

Education

M.S. - Clinical Service Operations

Harvard Medical School
Cambridge, MA
01.2023

M.B.A. - Pharmaceutical and Healthcare Marketing

Erivan Haub School of Business, St. Joseph’s University
05-2014

M.S. - Advanced Biotechnology

Thomas Jefferson University
Philadelphia, PA
08-2008

B.S. - Biotechnology/Applied Molecular Science

Thomas Jefferson University
Philadelphia, PA
05-2006

Skills

  • Global Regulatory Affairs
  • Health Authority Interactions
  • Regulatory Documentation
  • Process Improvement
  • Regulatory Software
  • Clinical Trial Phases
  • Data Analysis and Visualization
  • Guidelines Knowledge
  • Project Management
  • Oncology
  • Vaccines & Infectious Diseases
  • Cross-functional Collaboration
  • Scientific writing
  • Safety processes and procedures
  • Training and mentoring
  • Results analysis
  • Project management
  • Data analytics
  • Cell culture techniques
  • Advanced research techniques
  • Technical presentations
  • Machine learning
  • Intellectual property
  • Assay development
  • Research and experiments
  • Experimental design
  • Protein purification
  • Statistical modeling
  • Research management
  • Bioinformatics analysis
  • Genetic engineering
  • Drug discovery
  • Expert data analysis
  • Lab experiments and research
  • Technology transfer
  • Application of scientific principles
  • Laboratory techniques
  • Research methods
  • Quantitative skills
  • Teamwork
  • Teamwork and collaboration
  • Problem-solving
  • Problem-solving abilities
  • Time management
  • Organizational skills
  • Attention to detail
  • Scientific method
  • Data entry
  • Critical thinking
  • Quality control testing

Certification

Lean Six Sigma Yellow Belt

Affiliations

  • Sigma Xi Scientific Research Society, Member and Distinguished Graduate Student Presenter
  • Youth Minister, Catholic Archdiocese of Philadelphia
  • Harvard Innovation Labs

Timeline

Senior Scientist, Regulatory Affairs – Oncology & Biologics

Merck
10.2021 - Current

Senior Scientist, Regulatory Affairs – Oncology & Biologics

Harvard Medical School - Harvard Innovation Labs - Merck
01.2021 - 05.2023

Senior Scientist, Regulatory Affairs – Oncology & Biologics

Merck & Co.
01.2021 - 01.2022

Manager, Quality Control - Vaccine Global Operations

Merck & Co.
01.2019 - 01.2021

Laboratory Biotechnologist – Vaccine Laboratory Operations

Merck & Co.
01.2008 - 01.2012

Research Associate, siRNA In Vivo Delivery Biology Team Member

Merck & Co.
01.2007 - 01.2008

M.S. - Clinical Service Operations

Harvard Medical School

M.B.A. - Pharmaceutical and Healthcare Marketing

Erivan Haub School of Business, St. Joseph’s University

M.S. - Advanced Biotechnology

Thomas Jefferson University

B.S. - Biotechnology/Applied Molecular Science

Thomas Jefferson University

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