Shaik Nazeer
Limerick,Ireland
Summary
Highly motivated and detail-oriented Regulatory Affairs professional with dual Master's degrees in Pharmacology and in Process Validation & Regulatory Affairs. Practical experience as a Clinical Trial Assistant at Nomad Life Sciences, where responsibilities included supporting ethics submissions, maintaining clinical documentation, and assisting with trial file management. Strong academic foundation in regulatory guidelines such as ICH-GCP, cGMP, EU MDR, and CTD/eCTD structure. Quick to learn regulatory software and documentation standards, with a passion for ensuring quality and compliance in all aspects of regulatory operations. Eager to contribute to a dynamic pharmaceutical team focused on global regulatory excellence.
Overview
1
1
year of professional experience
3
3
years of post-secondary education
1
1
Certification
Work history
Clinical Trial Assistant (Internship)
Nomad Life Sciences
Hyderabad
01.2023 - 09.2023
- Supported preparation of regulatory and ethics submission packages for clinical trials.
- Maintained Trial Master File (TMF) and Investigator Site Files (ISF) according to ICH-GCP.
- Assisted with site communications, document tracking, and compliance with timelines.
- Gained exposure to informed consent documentation and regulatory correspondence workflows.
- Safeguarded participant confidentiality through strict adherence to privacy regulations in record keeping.
- Assisted in recruitment of suitable candidates for various trials, improving enrolment rates.
Education
M.Sc. - Process Validation & Regulatory Affairs
Technological University of Shannon
09.2024 - 09.2025
M.Sc. - Pharmacology
Bharat Institute of Technology
09.2020 - 12.2022
Skills
- Regulatory Submissions (EU, FDA, CDSCO)
- CTD/eCTD Dossier Structure
- Clinical Trial Documentation (ICH-GCP)
- Quality Compliance & Risk Management
- Regulatory Document Review & Formatting
- Knowledge of cGMP, ISO 13485, EU MDR
- Microsoft Office (Word, Excel, Outlook)
- Documentation & Record Management
Certification
Clinical Research and Pharmacovigilance
Project
Msc in Pharmacology:
EVALUATION OF ANTI-INFLAMMATORY AND ANALGESIC POTENTIALS OF CARICA PAPAYA L. USING IN-VITRO AND IN-VIVO MODELS, The leaf extraction of carica papaya was used to evaluate analgesic activity by acetic acid induced writing test and Tail immersion test in rat models and anti-inflammatory activity done by carrageenan induced paw edema method in rat models. when compared to methanolic and ethanolic extracts methanolic extracts was found to be more potent than ethanolic extracts.
Msc in Process Validation and Regulatory Affairs:
EVALUATING MODERN RISK ASSESSMENT PRACTICES IN MEDICAL DEVICE (DUAL CHAMBER PACEMAKER) PROCESS VALIDATION: ENSURING QUALITY AND COMPLIANCE
Personal Information
Visa status: Stamp 2 (Eligible for Stamp 1G in 10/2023)
Timeline
M.Sc. - Process Validation & Regulatory Affairs
Technological University of Shannon
09.2024 - 09.2025
Clinical Trial Assistant (Internship)
Nomad Life Sciences
01.2023 - 09.2023
M.Sc. - Pharmacology
Bharat Institute of Technology
09.2020 - 12.2022
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