Vinutha Kasthala

I’m a regulatory affairs specialist, skillfully ensuring that products comply with all necessary legal and safety regulations. I dive into the nitty-gritty of documentation and work closely with regulatory agencies to secure approvals. My job is all about balancing innovation with compliance to get solutions to market smoothly.

ExperienceRegulatory Affairs Specialist / ScieGen Pharmaceuticals - Hauppauge, NY   08/2023 - 06/2025 

• Facilitated preparation, formatting, and quality review of regulatory documents including IND submissions and annual reports.
• Conducted detailed quality control checks to ensure compliance with FDA and internal guidelines.
• Tracked submission statuses and document versions through Documentum, maintaining comprehensive archives.
• Reviewed localized documents against master versions to verify accuracy and consistency.
• Provided crucial administrative and technical support for regulatory queries and submission reviews.
• Collaborated with regulatory leads and publishing teams to expedite timely IND amendments and other filings.

• Reviewed and designed medical device labeling to comply with global regulatory standards, including 21 CFR Part 801 and EU MDR 2017/745.
• Led internal peer and expert reviews of labeling documents to ensure adherence to regulatory and quality standards.
• Managed Labeling Attribute Master Plans while supporting effective documentation practices across various projects.
• Facilitated label transition from MDD to MDR under EU MDR 2017/745 regulations, ensuring timely updates and audit readiness.
• Maintained quality documentation, including meeting minutes, query trackers, and Smartsheet dashboards for project alignment.
• Collaborated with cross-functional teams to ensure label accuracy, compliance, and alignment with product development timelines.
• Ensured high-quality record-keeping and version control for all labeling-related documents.

Bachelor of Science -Bio Medical Engineering 01/2017-01/2021

Saveetha School of Engineering - Chennai, India