Princy Shah
Queens,NY
Summary
A goal-oriented, self-motivated graduate looking to work in Regulatory Affairs, preparing and supporting submissions and change orders, including gathering technical documentation and drafting submissions to support the registration of pharmaceuticals and medical devices.
Overview
3
3
years of professional experience
Work History
Regulatory Affairs Intern
SMK Global
05.2023 - Current
- Streamlined regulatory submission process by organizing and maintaining documentation.
- Enhanced compliance with FDA regulations by conducting thorough research and analysis.
- Supported the development of regulatory strategies for new products, ensuring timely market entry.
- Facilitated communication between company and regulatory agencies during product review process.
- Analyzed competitor products for best practices in compliance, informing our own regulatory approach.
- Conducted gap analyses to assess compliance readiness, resulting in targeted improvement initiatives.
- Evaluated promotional materials for adherence to regulations, minimizing potential risks associated with off-label promotion or false claims.
- Assisted senior staff members in developing internal audits plans that ensured preparedness during external reviews.
- Collaborated with quality assurance department to guarantee that products met regulatory standards while in production, reducing the likelihood of product recalls or enforcement actions.
- Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
Regulatory Affairs Intern
Swiss Exports Pvt. Ltd.
07.2021 - 07.2022
- Read and correlated FDA, ICH and CDSCO (India) guidance documents
- Understood the application of USP monographs in regulatory submissions
- Prepare and submitted eCTD, ACTD and CTD
- Prepared company's literature/labeling and marketing material
- Assisted in the preparation of regulatory submissions for timely approvals.
- Enhanced compliance with FDA regulations by conducting thorough research and analysis.
- Supported the development of regulatory strategies for new products, ensuring timely market entry.
- Facilitated communication between company and regulatory agencies during product review process.
- Prepared necessary documentation for annual report submissions, ensuring accuracy and timeliness of information provided to regulators.
- Supported the regulatory process to help acquire Halal Certificate (India)
- Led the document preparation for application of dietary supplement
- Collaborated with quality assurance department to guarantee that products met regulatory standards while in production, reducing the likelihood of product recalls or enforcement actions.
Education
MS in Drug Regulatory Affairs -
Long Island University
03.2024
Bachelor of Pharmacy -
Gujarat Technological University
06.2021
Skills
- Regulatory Submission
- Technical Writing
- Document Review
- Microsoft Office
- Communication
- Document Management
- Pharmaceutical Regulations
- FDA regulations
- Dietary Supplements Regulation
- Multitasking Abilities
- Team building
Independent Course Work
Apex Formulations Pvt. Ltd., India, Training in production and quality control department.
Timeline
Regulatory Affairs Intern
SMK Global
05.2023 - Current
Regulatory Affairs Intern
Swiss Exports Pvt. Ltd.
07.2021 - 07.2022
MS in Drug Regulatory Affairs -
Long Island University
Bachelor of Pharmacy -
Gujarat Technological University
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