Fahreen Kayamali
Harrow,middlesex
Summary
A highly motivated life sciences graduate with 1st Class Honors in MSc Clinical Drug Development and hands-on experience in regulatory affairs and clinical research. Strong background in regulatory compliance, dossier preparation, post-marketing surveillance, and change control processes. Skilled in monitoring regulatory intelligence, managing documentation, and ensuring compliance with ICH-GCP, biocidal regulations, and pharmaceutical legislation. Fluent in English with proficiency in Microsoft Office and data management tools. Eligible to work in the UK.
Overview
2
2
years of professional experience
4
4
years of post-secondary education
1
1
Certification
Work History
Clinical Trial Intern
Aga Khan University Hospital,
Nairobi, Kenya, Parklands
03.2024 - 07.2024
- Updated and maintained the Trial Master File (TMF) to ensure compliance with regulatory requirements.
- Managed and tracked Case Report Forms (CRFs), data queries, and site documentation.
- Assisted in verifying medical records, source documentation, and regulatory submissions to enhance data accuracy.
- Supported the preparation, distribution, and archiving of clinical and regulatory documentation in line with SOPs.
Regulatory affairs assistant
Private Consultant (Harley’s)
Dar-es-Salaam, Tanzania
12.2023 - 03.2024
- Assisted in regulatory dossier preparation and updates for 8 products, ensuring compliance with biocidal and pharmaceutical regulations (TFDA/ICH-GCP).
- Managed and tracked 10 product variations, improving submission efficiency and approval rates.
- Reviewed label claims, supporting documentation, and product artwork to ensure compliance with regulatory standards.
- Supported regulatory intelligence monitoring, summarizing and documenting key legislative updates.
- Provided administrative support for change control processes, ensuring compliance with internal and external deadlines.
Student Research Assistant
University of Birmingham (Medical School),
Birmingham, West midlands
01.2022 - 05.2022
- Investigated Ataxia Telangiectasia (AT) in Drosophila, performing ATM gene silencing to study its role in DNA repair mechanisms.
- Conducted Drosophila handling, genetic crosses, and transgene manipulation, ensuring controlled experimental conditions.
- Performed live imaging and immunostaining using UAS-CD8::GFP to visualize motor neurons, enhancing understanding of neuronal development.
- Studied temperature-dependent phenotypic analysis of the TrpA1 channel, assessing its effects on larval CNS at 27°C and above.
- Executed data collection and analysis, recording larval, pupal, and adult counts to track phenotypic outcomes effectively.
Education
Master of Science - MSc in Clinical Drug Development
Queen Mary, University of London
London 09.2022 - 12.2023
Bachelor of Science - Biomedical Sciences
University of Birmingham
Birmingham 09.2019 - 07.2022
Skills
- Regulatory Compliance (ICH-GCP, TFDA, EMA, Biocidal Product Regulations)
- Time management
- Effective communication
- Data analysis
- Query resolution
- Dossier Preparation & Submission
- Change Control Process & Regulatory Intelligence Monitoring
- Labeling, Artwork Review, and Post-Marketing Surveillance
- Pharmaceutical & Biocidal Product Regulations
- Clinical Documentation & TMF Management
- Cross-Functional Collaboration & Administrative Support
- Microsoft Office (Word, Excel, PowerPoint), Medidata, Anova, SPSS
- Team player
Certification
• ICH-GCP E6 (R2) (Sue Fitzpatrick)
• CITI (GCP) & CITP (Investigator Training Program)
Languages
English
Fluent
Swahili
Fluent
Gujarati
Native
Timeline
Clinical Trial Intern
Aga Khan University Hospital,
03.2024 - 07.2024
Regulatory affairs assistant
Private Consultant (Harley’s)
12.2023 - 03.2024
Master of Science - MSc in Clinical Drug Development
Queen Mary, University of London
09.2022 - 12.2023
Student Research Assistant
University of Birmingham (Medical School),
01.2022 - 05.2022
Bachelor of Science - Biomedical Sciences
University of Birmingham
09.2019 - 07.2022
• ICH-GCP E6 (R2) (Sue Fitzpatrick)
• CITI (GCP) & CITP (Investigator Training Program)
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