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)