Kirthana Jeyachandran
Auckland,AUK
Summary
Regulatory affairs professional with strong expertise in regulatory compliance, documentation, and submission processes. Known for effective collaboration with cross-functional teams and results-driven approach. Skilled in regulatory strategy, risk assessment, and ensuring adherence to industry standards. Adaptable and reliable, excelling in dynamic environments.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Associate
Parexel International
03.2024 - 08.2024
- Coordinated and executed regulatory submissions for global clinical trials across APAC, EU, and North America, ensuring compliance with ICH-GCP, Medsafe, and regional regulatory requirements.
- Developed and managed regulatory submission plans in alignment with global project timelines and clinical development goals.
- Prepared, reviewed, and submitted Clinical Trial Applications (CTAs), Investigational New Drug (IND) applications, and related documents including Investigator Brochures (IBs), Protocols, and Informed Consent Forms (ICFs).
- Set-up and attend relevant trial alignment, kick -off and planning meetings with all relevant stakeholders and facilitate discussions for finalising the submission strategy.
- Maintained submission tracking systems and ensured up-to-date documentation across internal and external regulatory databases.
- Monitored evolving international regulatory landscapes to adapt submission strategies proactively and reduce approval times.
- Acted as a key point of contact for global regulatory authorities, responding to inquiries and deficiency letters efficiently and accurately.
Junior Regulatory Affairs Associate
Parexel International
06.2021 - 03.2024
- Conducted thorough reviews of labelling content for accuracy and adherence to relevant regulations before submission to authorities.
- Assisted in the preparation of regulatory submissions for clinical trial applications.
- Supported as Quality check member of regulatory packages to ensure completeness, compliance and accuracy.
- Supported regulatory intelligence gathering and analysis to inform business development initiatives.
- Preparation of Investigational Medicinal Product comparative table for Initial clinical trials and Amendment applications.
Research Trainee
CSIR - Institute for Microbial Technology
01.2021 - 06.2021
- Developing an assay which will detect the presence of viral genome (COVID-19) in less than 4 hours.
- Validation of Cas13a protein-based assay to detect SARS CoV2 RNA
- Maintained detailed records of experimental procedures and results using electronic lab notebooks for easy reference by other researchers.
- Optimized lab operations by maintaining a clean, organized workspace and ensuring timely calibration of equipment.
Education
Master of Science (Integrated) - Biotechnology
Vellore Institute of Technology
India06-2021
Advanced Diploma - Drug Regulatory Affairs
Jamia Hamdard University
India12-2024
Skills
- Medsafe, TGA, FDA, EMA
- Adverse event reporting
- ICH-GCP Compliance
- Clinical trial documentation
- Regulatory Intelligence and strategy
- Stakeholder collaboration
- Electronic document management systems (Veeva-vault, eCTD)
- Technical Writing and document review
Certification
- Introduction to Principles and Practices of Clinical research - The National Institutes of Health (NIH)
- Good clinical Practice - The National Institute on Drug Abuse (NIDA)
Timeline
Regulatory Affairs Associate
Parexel International
03.2024 - 08.2024
Junior Regulatory Affairs Associate
Parexel International
06.2021 - 03.2024
Research Trainee
CSIR - Institute for Microbial Technology
01.2021 - 06.2021
Master of Science (Integrated) - Biotechnology
Vellore Institute of Technology
Advanced Diploma - Drug Regulatory Affairs
Jamia Hamdard University
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