Shambhavi Parihar
Sanford,FL
Summary
- Regulatory Affairs professional with 3+ years of experience supporting global pharmaceuticals and medical device regulatory strategy, product registrations, and compliance lifecycle management.
- Skilled in eCTD dossier preparation, regulatory intelligence, ISO 13485 quality systems, ISO 14971 risk management, and cross-functional regulatory project execution.
- Experienced in maintaining regulatory information management systems (RIMS), interpreting evolving global regulations, and ensuring timely implementation of regulatory requirements across product portfolios.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Regulatory & Compliance Associate
Blue Cross Blue Shield
North Carolina
04.2025 - Current
- Integrate regulatory strategy into enterprise-wide projects by analyzing state and federal regulations and assessing compliance impact.
- Maintain regulatory data and workflows in SAI360 (regulatory management system) to track mandates, implementation timelines, and reporting requirements.
- Support execution of a $15.7M regulatory portfolio across 28 cross-functional projects to ensure timely regulatory implementation.
- Develop regulatory procedures, workflows, and compliance tracking tools to strengthen governance and audit readiness.
- Generate regulatory status reports and provide regulatory guidance to business stakeholders.
Consultant – IP Management & Compliance
Center for Research Innovation | Northeastern University
09.2023 - 04.2025
- Maintained regulatory and compliance data within enterprise data management system to ensure data integrity, traceability, and audit readiness.
- Prepared statutory reports and regulatory filings to maintain federal compliance (Bayh-Dole).
- Developed standardized quality workflows and documentation procedures to improve regulatory submission accuracy.
Regulatory Affairs Specialist (Medical Device – Capstone)
Neutron Therapeutics
Boston
09.2024 - 12.2024
- Conducted regulatory gap analysis for Class II radiation therapy medical device to assess compliance with FDA and international requirements.
- Supported preparation of technical documentation aligned with global regulatory frameworks and design control requirements.
- Developed cybersecurity and risk mitigation strategy aligned with EU MDR, GDPR, HIPAA, and ISO 14971.
- Contributed to regulatory strategy discussions for product development and market authorization planning.
In-House Counsel – Legal & Compliance
Bharat Biotech International Ltd
02.2020 - 02.2022
- Supported regulatory compliance activities during COVID-19 vaccine approval and commercialization.
- Reviewed clinical protocols, regulatory guidance, SOPs, and safety reporting requirements to ensure compliance with global regulatory standards.
- Collaborated with regulatory, clinical, and quality teams on product liability, adverse event reporting, and protocol adherence.
Education
Master of Science - Regulatory Affairs
Northeastern University
12-2024
J.D. - Law
Indian Institute of Technology
05-2016
Bachelor of Science - Biotechnology
SVBP University of Agriculture & Technology
05-2013
Skills
- Global Regulatory Strategy
- Medical Device
- STED & Technical Documentation
- Product Registrations
- 21 CFR 807/812/814
- ISO 13485
- ISO 14971
- IEC 62304
- EU MDR
- Regulatory Intelligence & Impact Assessment
- Regulatory Information Management Systems (RIMS)
- Risk Management
- Gap Analysis
- Cross-Functional Collaboration
- Regulatory Procedure Development
- Compliance Documentation Support
- Post-Market Surveillance
Certification
- ORAQ Regulatory Affairs Training Program – Duke University
- Good Clinical Practice (GCP) – Novartis
- Regulatory Affairs Professional Society (Member)
Timeline
Regulatory & Compliance Associate
Blue Cross Blue Shield
04.2025 - Current
Regulatory Affairs Specialist (Medical Device – Capstone)
Neutron Therapeutics
09.2024 - 12.2024
Consultant – IP Management & Compliance
Center for Research Innovation | Northeastern University
09.2023 - 04.2025
In-House Counsel – Legal & Compliance
Bharat Biotech International Ltd
02.2020 - 02.2022
Master of Science - Regulatory Affairs
Northeastern University
J.D. - Law
Indian Institute of Technology
Bachelor of Science - Biotechnology
SVBP University of Agriculture & Technology