Shauni Fitzgerald
Regulatory Affairs & Research Manager
Shauni Fitzgerald is the Regulatory Affairs & Research Manager at Atlantia Clinical Trials. Since joining the Atlantia team in 2020, she has played a key role in developing study proposals and overseeing protocol development and ethics submissions. With extensive expertise in clinical research operations, regulatory affairs, and document development, Shauni ensures compliance with ICH-GCP guidelines while maintaining scientific rigor.
Shauni has extensive expertise in EFSA and FDA regulations, excelling at advising sponsors on regulatory clarifications and considerations. Her ability to navigate complex regulatory frameworks has been instrumental in maintaining Atlantia's standard for high-quality data delivery. Shauni collaborates closely with sponsors and regulatory bodies to facilitate the smooth execution of clinical trials in different markets, while mitigating compliance risks.
Her background in both academic and industrial research allows her to bridge the gap between scientific rigor and regulatory requirements, ensuring the success of clinical studies from concept to completion.
Background & Credentials
Education & Training
- MSc in Nutritional Science, University College Cork
- PgCert in Food Regulatory Affairs, Ulster University
- BSc in Public Health & Health Promotion, University College Cork.
Expertise & Specialization
- Study & Protocol Design for Diverse Health Areas
- Regulatory Affairs
- Quality Control
- Compliance
- Clinical Research Operations
Certifications
- ICH Good Clinical Practice (GCP)
- ISO14155 GCP for Medical Devices
Years of Experience
- 10 years experience in Academic and Clinical Research
Experience
Total Years of Experience: 10 years in academic and clinical research.
Career Journey: Shauni began her career in academic research support. During this time, Shauni completed an ICH-GCP course which sparked her interest in clinical research and trials. She transitioned to haematology and oncology clinical trials before joining Atlantia's operations team as a Project Manager. In 2021, Shauni moved into the Atlantia Science team, where she contributed to study design and protocol development, and later assumed a regulatory affairs role within the teams.
Key Contributions: Ensuring adherence to regulatory requirements, overseeing study protocol development, and maintaining compliance with industry standards.
Role in the Company
- As the Regulatory Affairs & Research Manager at Atlantia Clinical Trials, Shauni is responsible for advising sponsors on, and ensuring regulatory compliance, supporting study design, and managing ethics submissions. She plays a crucial role in protocol development and liaises with regulatory authorities to uphold industry standards.
- Key Projects worked on: Shauni has been an instrumental member of the clinical team behind multiple trials serving different therapeutic areas such as stress, cognition, women's health, skin health, cardiovascular health, metabolism, gut health, microbiome, immunology, nutrition, and bioavailability.