SOUNDARYA P
Chennai
Summary
Regulatory affairs professional with over 4 years of experience in SMB publishing. Specializes in managing IND, NDA, ANDA, and DMF submissions for US FDA in CTD/eCTD formats. Actively involved in EU regulatory submissions. Driven to apply academic knowledge and internship experience to ensure regulatory compliance, timely submissions, and product safety on a global scale.
Overview
9
9
years of professional experience
Work History
JUNIOR REGULATORY ASSOCIATE
Navitas Life Sciences Pvt Ltd.
04.2022 - Current
- Being a part of SMB Project Team, supporting the submission of various FDA-regulated electronic submissions, including IND, NDA, ANDA – OPDP, Annual Reports, US Structured Product Labeling (SPL), US-Major, and DMF submissions and amendments, ensuring accuracy, quality, and compliance with agency standards.
- Worked on European regulatory submissions in alignment with EMA guidelines, including ASMF, Initial MAA, CEP and Variations, maintaining strict adherence to regional regulatory requirements and quality standards.
- Provided end-to-end publishing support, including DLP, ensuring all regulatory submissions were completed within required timelines and met quality and completeness standards.
- Currently authoring a regulatory-focused article, contributing to ongoing professional development and thought leadership in the regulatory affairs domain.
REGULATORY ASSOCIATE INTERN
Navitas LLP
03.2021 - 03.2022
- Gained hands-on experience in document-level publishing, including bookmarking, hypertext linking, and preparation of Tables of Contents in alignment with health authority guidelines and eCTD structure requirements.
- Developed a foundational understanding of regulatory submission types such as IND, ANDA, NDA, and DMF in CTD/eCTD formats for major regulatory bodies including the US FDA and EMA.
- Assisted in FNF of regulatory submissions, ensuring compliance with agency specifications and submission timelines.
- Supported submission publishing activities, including meeting request packages and promotional material submissions
HR Executive/Admin/Accounts Assistant
CIAR Software Solutions Pvt Ltd
01.2017 - 02.2021
Education
B.E - Computer Science Engineering
J.J. College of Engineering and Technology
Tiruchirappalli, TN05.2016
Hr.Sec: Matric -
Good Shepherd Matriculation Higher Secondary School
Tiruchirappalli, TN03.2012
TOOLS & SOFTWARES
- PharmaReady Publishing Tool
- ISI Toolbox
- LORENZ eValidator
- MS-Office
Hobbies and Interests
- Reading
- Art & Craft
- Movies & Music
- History & Monuments
Disclaimer
I hereby declare that the aforementioned details are true to the best of my knowledge.
Timeline
JUNIOR REGULATORY ASSOCIATE
Navitas Life Sciences Pvt Ltd.
04.2022 - Current
REGULATORY ASSOCIATE INTERN
Navitas LLP
03.2021 - 03.2022
HR Executive/Admin/Accounts Assistant
CIAR Software Solutions Pvt Ltd
01.2017 - 02.2021
Hr.Sec: Matric -
Good Shepherd Matriculation Higher Secondary School
B.E - Computer Science Engineering
J.J. College of Engineering and Technology
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