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.
Regulatory Affairs Specialist / TATA ELXSI - Pune, India
12/2021 - 04/2023
- 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.
