Parth Rastogi
Parth Rastogi
Regulatory Affairs Specialist
New Jersey, United States
RAPS MemberMS Reg. Affairs · NEU
Regulatory Affairs & Quality Assurance

Parth Rastogi

MS Regulatory Affairs · Northeastern University

BioPharmaceuticals · Medical Devices · Global Submissions

FDAEU MDRCTD/eCTDISO 13485510(k)cGMPVeeva Vault RIMeSTAR
ConnectView Experience
0
Years Experience
0
Products Submitted
0
Countries
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Publications
About
Summary

Regulatory Affairs Specialist with 2+ years of experience managing regulatory submissions, ensuring FDA and global regulatory compliance, and developing submission strategies for pharmaceutical and medical device products. My approach is "technical-first" — translating complex clinical data and global requirements into successful regulatory approvals.

At AXA Parenterals, I led submissions for 15+ sterile injectable products across 10+ countries, achieving first-time approvals in CTD & ACTD formats. Currently at Rebecca Everlene Trust Company, I contribute regulatory expertise to grant proposals, author white papers, and develop regulatory and technical documents aligned with Good Documentation Practices.

I also volunteer as a Medical Writer at Med Report Foundation, translating complex clinical and pharmacological information into clear, evidence-based content. I am passionate about streamlining the regulatory process to bring life-saving therapies to patients faster.

Open to Opportunities
New Jersey, United States
MS Regulatory Affairs · NEU
RAPS · ACS · SPER · ISPE

Countries

USAEULATAMAsiaAfricaCanada

Dossiers

NDA/ANDA510(k)eSTARPMAEU MDRCTDACTDeCTD

My technical core bridges the gap between traditional regulatory affairs and modern health tech.

Submission Strategy
Hands-on experience with CTD/eCTD dossier compilation, eSTAR templates, and 510(k)/PMA strategy.
Digital Health & AI
Specialized knowledge in Cybersecurity for Digital Health and VR-based cognitive device compliance.
Regulatory Systems & Tools
Proficiency in Veeva Vault RIM and ArisGlobal LifeSphere for lifecycle management and documentation. Skilled in MS Word, Excel, PowerPoint, and Visio, Adobe Acrobat Pro, and CorelDraw.
Global Compliance
Deep understanding of US (FDA), EU (MDR), and international (LATAM/Asia/Africa) market access requirements.
Work History
Professional Experience
2025 – Present
Rebecca Everlene Trust Company
Chicago, IL (Remote)
Regulatory Affairs Specialist
Sep 2025 – Present
Regulatory Writing · Grant Proposals
  • Contributing regulatory expertise to grant proposals, ensuring alignment with organizational policies and global compliance standards.
  • Developing and reviewing regulatory and technical documents, enhancing accuracy and adherence to Good Documentation Practices (GDP).
  • Authoring white papers translating complex regulatory requirements and technical data into clear, strategic narratives.
2021 – 2023
AXA Parenterals Ltd.
Roorkee, India
Drug Regulatory Affairs Officer
Jul 2021 – Aug 2023
Sterile Injectables · CTD/ACTD · Global Submissions
  • Achieved first-time approval by leading regulatory submissions for 15+ sterile injectable products across 10+ countries.
  • Compiled and submitted Module 1, 2 & 3 (CMC) documentation in alignment with ICH Q8–Q10 and FDA guidelines.
  • Coordinated cross-functional inputs from QA, Manufacturing, and R&D teams to meet submission timelines.
  • Conducted post-market safety surveillance for 15+ injectable products, monitoring adverse events (CIOMS, ICH E2D).
  • Prepared ICSR narratives and aggregate safety reports (PSUR/DSUR) in line with ICH E2 guidelines.
  • Reviewed and updated product labeling and artworks per U.S. FDA guidance (21 CFR Part 201).
  • Reviewed and validated critical quality documents to ensure compliance and support regulatory submissions.
  • Managed CAPA, deviation, and change control records, aligning with ISO 13485 and FDA QSR requirements.
2017 – 2018
Himalaya Wellness Company
Dehradun, India
Quality Assurance Research Analyst
Oct 2017 – Mar 2018
GMP · Herbal Drug QC · 21 CFR Part 111
  • Performed GMP documentation reviews ensuring accuracy and compliance with internal and regulatory standards.
  • Evaluated quality data and technical documents to support regulatory and audit readiness.
  • Maintained organized, audit-ready records contributing to successful quality inspections.
  • Maintained and verified laboratory documentation and CoA to support batch release decisions.
  • Executed and documented analytical testing activities in accordance with approved SOPs.
Volunteer Experience
Giving Back to Healthcare
Med Report Foundation
Remote
Medical Writer (Volunteer)
Present
Medical Writing · Evidence-Based Content
Core Competencies
Skills & Expertise

Regulatory Submissions

CTD/eCTD/ACTDNDA/ANDAIND510(k)PMAeSTAREU MDRCE MarkingMDSAP

Compliance & Quality

FDA 21 CFRcGMP (210/211)ISO 13485ISO 14971ICH Q8–Q10QMSChange ControlCAPAGap Analysis

Safety & Surveillance

PharmacovigilanceAE/SAE ReportingFAERS/REMSSignal DetectionPost-Market SurveillanceLabeling (21 CFR 201)

Regulatory Systems & Tools

Veeva Vault RIMArisGlobal LifeSphereGreenlight GuruSharePointAdobe Acrobat ProMS WordMS ExcelMS PowerPointMS VisioCorelDrawSPL/XML
Selected Work
Capstone & Academic Projects
Capstone Project · Northeastern University

Regulatory & Clinical Research — VR Medical Device (Virtuleap)

Regulatory & Clinical Research Intern · Virtuleap, Boston, MA
Apr 2025 – Jun 2025
Project 01

Global Regulatory Strategy — Class III Medical Device

Developed a regulatory strategy across the U.S. (PMA), EU (CE marking), Canada (MDL), Australia (TGA), Mexico (COFEPRIS), and Singapore (HSA) for market access.
Project 02

eSTAR Submission — IVD Medical Device

Designed and prepared a mock eSTAR submission for 510(k) of an in-vitro diagnostic device intended for infectious disease detection.
Project 03

FAERS Data & REMS Analysis

Evaluated adverse event databases to develop risk mitigation strategies and improved pharmacovigilance compliance through data-driven safety assessments.
Research
Publications
Publication 01
An update on potential therapeutic actions of Boswellic acids
International Journal of Pharmaceutical Sciences and Research, 2021; 12(10): 5238-52
Rastogi P, Dwivedi PK · DOI: 10.13040/IJPSR.0975-8232.12(10).5238-52
Publication 02
An overview of recent studies on antibacterial, antifungal, antiviral and antioxidant potential of Tagetes patula
YMER, 2022; 21(11)
Rastogi P, Dwivedi PK · DOI: 10.37896/YMER21.11/03
Publication 03
An evidence-based update on the pharmacological activities of Tagetes patula
YMER, 2022; 21(11)
Rastogi P, Dwivedi PK · DOI: 10.37896/YMER21.11/15
Academic Background
Education
MS — Regulatory Affairs
Northeastern University · Boston, MA
Sep 2023 – Jun 2025
Regulatory Compliance, Medical Device Development, International Regulations, Strategic Planning, Process Validation, Cybersecurity in Digital Health.
Master of Pharmacology
Amity University · Lucknow, India
Apr 2019 – Mar 2021
Clinical Research & Pharmacovigilance, Pharmacology & Toxicology, Regulatory Affairs Studies, Principal Drug Discovery, Research Methodology & Biostatistics.
Bachelor of Pharmacy
Amity University · Lucknow, India
Apr 2014 – Mar 2018
Pharmacology, Organic & Inorganic Chemistry, Analytical Chemistry, Anatomy & Physiology, Pathology, Pharmacognosy, Drug Designing.
Professional Affiliations
RAPS
Student Member
ACS
Member
SPER
Life Member
ISPE
Member
Professional Credentials
Licenses & Certifications

CITICITI Program

Conflict of InterestGCP for Clinical Investigations of Devices

WHOWorld Health Organization

Vaccine Safety BasisIPC COVID-19

UMCUppsala Monitoring Centre

Introduction to PharmacovigilanceSignal Detection and Causality AssessmentStatistical Reasoning and Algorithms in Pharmacovigilance

RAPSRAPS

510(k) Submission Process
Get in Touch
Let's Connect.

Seeking roles in Regulatory Affairs, Quality Assurance, and Clinical Research across the U.S.