Joshua Alimi
North London
Summary
Experienced regulatory professional with expertise in electronic Common Technical Document (eCTD) submission formats and regulatory documentation workflows. Proficient in advanced Excel, SQL for audit checks and data validation, and Power BI for creating regulatory dashboards and reporting. Demonstrates a strong understanding of GxP principles, data integrity (ALCOA+), and compliance with regulatory frameworks governing medicinal products. Skilled in the preparation, review, and management of regulatory documentation, including Summary of Product Characteristics and Patient Information Leaflets. Adept at maintaining compliant documentation, supporting inspections, and ensuring adherence to regulatory standards across the medicinal product lifecycle from development to post-marketing activities. Committed to driving excellence in regulatory processes while supporting organisational goals within the pharmaceutical sector.
Overview
8
8
years of professional experience
2026
2026
years of post-secondary education
Work history
DATA ACQUISITION QUALITY SPECIALIST (Regulatory Classification & Compliance)
Medicines and Healthcare products Regulatory Agency (MHRA)
2025.02 - 2026.03
- Apply UK regulatory frameworks and internal MHRA guidance to assess and classify medicinal product information within regulatory systems, ensuring alignment with UK medicines legislation and regulatory data governance standards.
- Perform detailed validation and quality assurance checks on regulatory records to ensure completeness, accuracy, and compliance with regulatory data integrity principles (ALCOA+).
- Maintain clear and traceable documentation of regulatory decisions, supporting audit readiness and compliance with internal governance and regulatory authority requirements.
- Identify inconsistencies, data anomalies, or potential compliance risks within regulatory datasets and escalate findings to Regulatory Affairs and Quality teams for review and resolution.
- Contribute to integrity and maintenance of medicinal product regulatory records that support regulatory lifecycle management and pharmacovigilance activities.
- Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, and technical specialists to strengthen regulatory data governance and improve regulatory workflows.
- Support continuous improvement initiatives for regulatory processes and Standard Operating Procedures (SOPs) to enhance submission accuracy and operational efficiency.
- Ensure compliant handling and governance of sensitive regulatory information within regulated systems aligned with GxP and regulatory authority standards.
- Demonstrate familiarity with regulatory submission structures including electronic Common Technical Document (eCTD) formats and regulatory documentation such as Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL).
DATA ANALYTICS & IT SUPPORT
North London PC
North London
2018.02 - 2021.01
- Maintained accurate operational documentation and system records to support internal compliance requirements and quality management processes.
- Generated structured analytical reports and dashboards to support management decision-making and operational process improvements.
- Provided IT and data support within environments handling confidential and sensitive information, ensuring adherence to data protection regulations and information governance standards
- Performed validation checks and data quality reviews to ensure integrity and accuracy of operational datasets used in business processes.
- Supported troubleshooting and resolution of system and data issues, ensuring minimal disruption to operational workflows and maintaining reliable system performance.
- Reinforced best practices in documentation control, data governance, and secure handling of sensitive information in line with organisational policies.
Education
BSc (Hons) - Biomedical Science
Birmingham City University
A Levels - Biology, Psychology, Computer Science
Alec Reed Academy
2017.01 - 2019.01
Skills
- Understanding of electronic Common Technical Document (eCTD) submission formats and regulatory documentation workflows
- Excel (advanced), SQL (audit checks and data validation), Power BI (regulatory dashboards/reporting)
- Understanding of GxP, data integrity (ALCOA), and regulatory quality principles
- Knowledge of regulatory frameworks governing medicinal products and compliance with regulatory authority requirements
- Familiarity with preparation, review, and management of regulatory documentation including Summary of Product Characteristics and Patient Information Leaflets
- Ability to maintain compliant documentation, support inspections, and ensure adherence to regulatory standards
- Awareness of regulatory processes across medicinal product lifecycle from development and submission to post-marketing activities
Websites
Timeline
DATA ACQUISITION QUALITY SPECIALIST (Regulatory Classification & Compliance)
Medicines and Healthcare products Regulatory Agency (MHRA)
2025.02 - 2026.03
DATA ANALYTICS & IT SUPPORT
North London PC
2018.02 - 2021.01
A Levels - Biology, Psychology, Computer Science
Alec Reed Academy
2017.01 - 2019.01
BSc (Hons) - Biomedical Science
Birmingham City University