---
title: 002
description: A consultant with The FDA Group.
---

[The FDA Group's Consultant Finder ](https://www.thefdagroup.com/find-consultants)

# [002](https://www.thefdagroup.com/find-consultants/002)

 Written by [The FDA Group](https://www.thefdagroup.com/find-consultants/author/the-fda-group) | Mar 10, 2022 4:27:51 PM

**Key Areas of Expertise**

- Regulatory Strategy and FDA Submissions (IND, BLA, NDA, ANDA, PMA)
- CMC and Labeling Review for Biologics and Drugs
- Quality System Development and Compliance (cGMP, ICH, EMA)
- FDA Inspection Readiness and Remediation (FDA 483s, Warning Letters)
- Biologics Manufacturing and Process Development

**Professional Experience**

*Senior Industry Consultant* – FDA Group LLC  
Westborough, MA | Jan 2015-Present

- Advised clients on regulatory strategy, clinical development, and technical aspects of regulatory submissions, including quality sections of Pre-IND, IND, NDA, and BLA documents.
- Conducted cGxP audits for domestic and international manufacturing sites, providing FDA-483 remediation support and guidance on responding to Warning Letters and Consent Decrees.
- Led due diligence audits for global investment firms and vendor qualification for drugs and biologics manufacturers.
- Provided expert regulatory support as an FDA witness for legal cases involving patent infringement, labeling, and compliance issues.

*Director, Regulatory Affairs (Head CMC)* – Kashiv BioSciences  
Piscataway, NJ | Jan 2019-Nov 2019

- Directed global regulatory and CMC programs for biosimilar therapeutics, leading analytical development, method validation, and BLA submissions to FDA, EMA, and DCGI India.
- Supervised a team of regulatory scientists, developed policies and SOPs, and hosted FDA inspections.
- Led Type C and BPD Type 2 meetings with the FDA to address compliance issues for U.S. and Indian manufacturing sites.

*Senior Manager, Regulatory Affairs* – Emergent BioSolutions, Inc.  
Gaithersburg, MD | Sept 2017-Oct 2018

- Developed regulatory strategies for the Vaccine and Anti-Infective Business Unit, overseeing regulatory submissions, BLA supplements, and agency meetings.
- Served as the regulatory lead for vaccine projects, including technology transfer of Raxibacumab from GSK, and managed regulatory compliance at multiple manufacturing facilities.

*Scientific Liaison* – United States Pharmacopeia (USP)  
Rockville, MD | Aug 2015-Jun 2017

- Managed USP’s Nomenclature and Labeling Expert Panel, collaborated with FDA and global stakeholders, and conducted cGMP audits for dietary supplement manufacturing plants as part of the USP verification program.

*Regulatory Affairs Manager* – Medefil, Inc.  
Glendale Heights, IL | Apr 2015-Aug 2015

- Served as the corporate liaison for regulatory submissions, managed QMS compliance, and directed post-marketing surveillance, customer complaints, and drug listing programs.

*Research Fellow* – Center for Cancer Research, NCI, NIH  
Bethesda, MD | Oct 2013-Mar 2015

- Led cancer research projects on hormone receptor interactions, directed development of UV laser cross-linking technology, and contributed to NIH U01 grant applications.

*Principal Investigator and Drug Quality Reviewer* – Office of Biotechnology Products, CDER, FDA  
Bethesda, MD | Nov 2005-Oct 2013

- Conducted quality reviews for over 30 IND applications, 100 pre-IND submissions, and six BLAs for therapeutic proteins and monoclonal antibodies.
- Developed CMC policies for biosimilars, led cross-center collaborative projects, and published research in high-impact journals.

**Education**  
Ph.D. in Chemistry  
University of Allahabad

Master of Science in Chemistry  
Bundelkhand University

**Certifications**  
Certified Quality Auditor – ASQ

**Professional Affiliations**

- Regulatory Affairs Professional Society (RAPS)
- Senior Member, American Society of Quality (ASQ)

**Publications and Presentations**

- Authored 27 research articles in journals such as *Molecular Cell* and *PNAS*. Presented over 30 talks at national and international meetings.

**Awards**

- NIH Director’s Performance Award (2005)
- Fellows Award for Research Excellence, NIH (2004)
- Individual Cash Awards for Performance, CDER, FDA (2008-2011)

[View full post](https://www.thefdagroup.com/find-consultants/002)

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