Drug Development & Regulatory Affairs Professional
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Drug Development Professional with 8+ years of experience in Regulatory Affairs, Clinical Trial Management, and Project Delivery within pharmaceutical and biotech industries. Experienced in IND submissions, eCTD publishing, Veeva Vault (eTMF/RIM), FDA compliance, and clinical trial operations supporting Phase I–III studies. Strong track record of improving operational efficiency, ensuring inspection readiness, and collaborating with cross-functional teams to accelerate regulatory approvals and clinical timelines.
Skilled in project coordination, stakeholder management, compliance documentation, and process optimization.
Merck Pharmaceuticals – Rahway, NJ
Sep 2023 – Jan 2026
Led cross-functional clinical operations for biomarker programs across Phase II–III trials.
Developed KPI dashboards using Power BI and Smartsheet, improving reporting efficiency.
Served as SME for Veeva Vault eTMF and supported audit-ready documentation.
Managed biomarker sample logistics and global shipment tracking.
Implemented risk mitigation strategies and standardized workflows to improve operational efficiency.
Bayer Pharmaceuticals – Whippany, NJ
May 2022 – Aug 2023
Prepared and submitted CMC regulatory documents including INDs and FDA responses.
Managed eCTD publishing and ESG submissions through Veeva Vault.
Collaborated with QA, Manufacturing, and Regulatory teams to meet submission timelines.
Maintained regulatory tracking systems and improved audit readiness processes.
Gilead Sciences – Morris Plains, NJ
Apr 2021 – May 2022
Managed Trial Master File (TMF) activities ensuring compliance with ICH-GCP standards.
Reviewed CRA monitoring reports and Serious Adverse Events (SAEs).
Supported TMF migration projects and improved document processing workflows.
Tracked study milestones using CTMS and EDC systems.
Gilead Sciences – Morris Plains, NJ
Aug 2020 – Apr 2021
Conducted quality review of clinical documentation and supported monitoring visits.
Coordinated study meetings, action items, and eTMF document filing.
Assisted CRAs in ensuring site compliance and timely documentation.
Nuworld – Carteret, NJ
Jan 2018 – May 2020
Managed regulatory documentation for OTC cosmetic products.
Reviewed clinical and safety data for product claims and approvals.
Developed compliance tracking systems and supported audits.
Drugfield Pharmaceuticals – Lagos, Nigeria
Oct 2015 – Nov 2017
Reviewed manufacturing batch records and QA documentation.
Conducted quality audits and supported regulatory compliance activities.
Coordinated logistics and collaborated with QA and production teams.
MBA, Healthcare Management – Western Governors University (2024)
MSc, Drug Discovery and Development – University of Sunderland (2015)
BSc, Pharmaceutical and Cosmetic Science – De Montfort University (2013)
Project Management Professional (PMP) – PMI (2024)
Certificate in Strategy Execution – Harvard Business School (2025)
Good Clinical Practice (GCP) – NIDA Clinical Trials Network
Regulatory Affairs Certification (RAC – Drugs) – Expected 2026
ACRP Certified Professional (ACRP-CP) – Expected 2026
