Amina Siddiqui
MA
Summary
Regulatory Affairs professional with a solid clinical foundation and training in FDA and EU regulations. Skilled in risk management and regulatory documentation, prioritizing patient safety and compliance.Looking to Shape Regulatory Standards Beyond the Chair.
Overview
14
14
years of professional experience
Work History
Regulatory Strategy Intern
InstantDetect Solutions Inc.
Boston, USA
09.2025 - Current
- Co-led global regulatory strategy development for Software as a Medical Device (SaMD) screening application, enhancing regulatory alignment.
- Supported creation of regulatory documentation and risk assessment, ensuring compliance with FDA 21 CFR Part 11, ISO 13485, IEC 62304, ISO 14971, and EU MDR.
- Contributed to compliance and market entry planning, facilitating safe global commercialization.
Academic Projects
Northeastern University
Boston, USA
01.2024 - Current
- Analyzed FDA’s Benefit-Risk framework using Pembrolizumab (Keytruda) as a case study.
- Developed regulatory strategy for novel product inspired by traditional remedies, ensuring compliance with industry standards.
- Created Pediatric Study Plan (PSP) for NDA/BLA-approved drug per FDA's PREA guidance, facilitating regulatory approval process.
- Assessed advertising/promotional regulations in the EU and US (Directive 2001/83/EC and 21 CFR).
- Completed coursework on the CTD and eCTD submission formats, gaining knowledge of global regulatory requirements, FDA-specific Module 1 content, and the structure of NDA, IND, and BLA filings.
- Completed advanced coursework in regulatory writing, emphasizing drafting and reviewing submission-ready documents aligned with FDA requirements and CTD format.
Dental Assistant
Hopkinton Dental Associates
Hopkinton, USA
08.2022 - 05.2023
- Assisted with procedures in high-volume US dental setting, utilizing four-handed dentistry to ensure quality patient treatment.
- Utilized iTero and CAD/CAM technologies to coordinate appointments and maintain detailed patient records, enhancing treatment efficiency.
Dental Surgeon
Dental Diagnostic Centre
Bangalore, India
10.2011 - 08.2012
Education
Master of Science - Regulatory Affairs
Northeastern University
Boston, MA05.2026
Bachelor of Dental Surgery -
Rajiv Gandhi University of Health Sciences
Bangalore, India06.2010
Skills
Regulatory Affairs & Compliance
- FDA Regulations & Compliance (Drugs, Devices, SaMD – foundational)
- Medical Device & Digital Health Regulations
- EU MDR (foundational knowledge)
- Product & Global Regulatory Strategy
- Good Clinical Practice (GCP)
- Post-Market Surveillance & Safety Reporting
- Risk Management (ISO 14971 – foundational)
Quality Systems & Documentation
- Quality Management Systems (ISO 13485 – exposure)
- Regulatory Writing & Technical Documentation
- Documentation Control & Compliance Tracking
- Data Integrity & Record Management
Clinical & Technical Insight
- Clinical Workflow Understanding & Patient Safety
- Digital Imaging & Diagnostics (iTero, CAD/CAM, Digital Radiography)
- Infection Control
Professional Skills
- Cross-Functional Collaboration
- Stakeholder & Regulatory Communication
- Team coordination
Technical Tools
- Microsoft Office Suite (Excel, PowerPoint, Word, Outlook)
Timeline
Regulatory Strategy Intern
InstantDetect Solutions Inc.
09.2025 - Current
Academic Projects
Northeastern University
01.2024 - Current
Dental Assistant
Hopkinton Dental Associates
08.2022 - 05.2023
Dental Surgeon
Dental Diagnostic Centre
10.2011 - 08.2012
Master of Science - Regulatory Affairs
Northeastern University
Bachelor of Dental Surgery -
Rajiv Gandhi University of Health Sciences