Kayalvizhi
Summary
Regulatory Affairs Specialist with comprehensive experience in managing regulatory submissions and compliance across multiple therapeutic areas. Proven ability to lead projects, including Clinical Trial Strategy and Submissions, while ensuring alignment with EMA, FDA, HSA, ICH, and ISO regulations. Skilled in overseeing the preparation and submission of Initial CTAs, Amendments, Product Registrations, License Renewals, and Variation Registrations (Clinical Trials and Post Marketing). Strong collaborator with health authorities and internal teams to drive timely approvals and maintain regulatory compliance. Known for a detail-oriented approach, exceptional organizational skills, and a commitment to delivering high-quality results.
Overview
7
7
years of professional experience
Work History
Regulatory Affairs Coordinator
AbbVie
03.2022 - Current
- Manage portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities such as substantial amendments, end of trial notifications etc
- Provide advice on submission strategy, country requirements, etc
- As well as operational support for Regulatory submission preparation and processing of amendments
- Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB, Protocols
- Ensure approved company CTA processes are followed within agreed timelines
- Monitor key project milestones (actual vs Planned activities and timelines) and identify and communicate issues/changes to assigned stakeholders and management as agreed in company procedures
- Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities
- Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly
SEA Regulatory Affairs Specialist
Avanos Medical
10.2021 - 03.2022
- Assist in providing regulatory input and technical guidance to global RA team on product regulatory requirements in assigned markets throughout a product lifecycle
- Coordinate post marketing surveillance activities such as FSCA, product recalls, adverse event reporting
- Assist and participate as appropriate in regulatory inspections and quality audits
- Communicated with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements and clarification and follow-up of submissions under review
Regulatory Affairs Specialist
Cognizant Technological Solutions
01.2020 - 10.2021
- Involved in quality check of regulatory documents (clinical, non- clinical, quality, response) and Dossier publishing
- Planning, undertaking, and overseeing regulatory submissions to health authorities (Local and International)
- Coordinated global regulatory projects and led several regulatory trainings for clients
- Ensured compliance with company state and federal requirements for all performed work
- Involved in internal and external Audits and SOP maintenance
Head of Department (Lifescience)
Mathvision Enrichment Centre
04.2019 - 12.2019
- Developed and implemented performance improvement strategies and plans to promote continuous improvement
- Led team of 35 teachers, overseeing hiring, training, and professional growth of employees
Research Associate
Singapore University Of Technology And Design
08.2017 - 03.2019
- Prepared and implemented design reviews for projects on Automation Methods using Robots (Healthcare Aided Robotics) in collaboration with Changi General Hospital
- Determined new concepts needed and researched new technologies that could be used
- Published Science Journals
- Prepared regulatory documentation and presentations and highlighted findings to support leads of company projects
Education
Master Of Science - Biomedical Engineering
Nanyang Technological University
Singapore05.2017
Bachelor Of Technology - Biomedical Engineering
SRM University
Chennai06.2015
Skills
- IB/Protocol/IMPD/SmPC Review
- EU-CTR Transition (CTIS)
- Initial CTA Application/eCTD
- Submission/Registration/Substantial Amendments/Renewals
- COSMOS/QUARTS
- EMA/FDA/HSA/ISO/ASEAN
- SOP Creation And Maintenance
- Adverse Reaction Reporting/CAPA
- Strategic Direction/Project Management
- Therapeutic Drugs and Medical Device Regulatory Strategies
Publications
Towards Robot-Aided Visual Sampling of Floor Dust in Indoor Settings, IEEE, 01/19
Timeline
Regulatory Affairs Coordinator
AbbVie
03.2022 - Current
SEA Regulatory Affairs Specialist
Avanos Medical
10.2021 - 03.2022
Regulatory Affairs Specialist
Cognizant Technological Solutions
01.2020 - 10.2021
Head of Department (Lifescience)
Mathvision Enrichment Centre
04.2019 - 12.2019
Research Associate
Singapore University Of Technology And Design
08.2017 - 03.2019
Master Of Science - Biomedical Engineering
Nanyang Technological University
Bachelor Of Technology - Biomedical Engineering
SRM University
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