Prachi Patel

Regulatory and Quality Compliance specialist with 5 years of experience supporting cGMP compliance, document review, and regulatory submissions for drugs, biologics and medical devices. Skilled in batch record review, QMS documentation, deviation management, and eCTD and 510k submissions in fast-paced GMP regulated environments. Adaptive, detail-oriented, and experienced collaborating across AI/ML, quality, regulatory, scientific and manufacturing teams.

Compliance Specialist CMC, Quality Assurance at Astellas Pharma (2025-11 – 2026-05)

• Led document review of manufacturing batch records, executed QC test records, CMC deviation records, stability data for cell and gene therapy, safeguarding product quality
• Identified and reported documentation errors and nonconformances from SOPs or specifications in real time, stopping issues before batch release
• Managed deviations, compliant handling, change control, CAPA activities, audit readiness efforts across QA operations while reducing recurring quality events
• Tracked project activities and document review metrics, risks, dependencies and action items giving the team visibility into review progress and completion status
• Enforced ALCOA+ data integrity principles across every review, keeping cGMP compliance intact ahead of inspection
• Supported FDA regulatory submission per global regulatory standards, closing the gap between site practice and regulatory expectation
• Filed, achieved, retrieved physical records on-site and to support inspection and FDA audit readiness
• Collaborated with scientific, QC, and manufacturing teams to resolve quality record issues, protecting compliance standards across functions

Regulatory Affairs Specialist I at MAE Group (2024-03 – 2024-12)

• Led medical device regulatory submissions and interacted with FDA regulatory agency, attended 3 FDA CDRH meetings
• Served as official correspondent and US agent for 6+ clients and supported FDA audits
• Maintained QMS documentation including quality manuals, factory profiles, calibration and production records
• Conducted regulatory assessments, risk management, and root cause analyses to support device submissions
• Prepared client-ready deliverables, including regulatory dossiers, assessments, requirements, status reports, business cases and implementation plans for domestic and global clients
• Advised clients on FDA quality and regulatory requirements shaping their product compliance approach

Quality and Regulatory Affairs Associate at Skylark Pharmaceuticals (2018-01 – 2021-04)

• Performed quality review of QC data, master batch records (MBR), calibration records and technical documents keeping GMP documentation audit-ready
• Supported in internal and external audits for cGMP compliance and led complaint handling and product recalls for pharmaceuticals driving continuous improvement
• Prepared 5 submission-ready drug regulatory dossiers for IND, NDA and ANDA submissions (quality, non-clinical, clinical) in CTD format compliant with regulatory requirements
• Led root cause analysis, CAPA, and deviation investigations that closed audit findings and reduced recurrence
• Maintained QMS, logbooks, laboratory notebooks, SOPs, batch manufacturing record for compliance activities
• Performed DMPK documents review, version control, editing, formatting and archival, keeping controlled GMP documents accurate and traceable

Executive MBA in Healthcare Management – New England College (2026-09)

Masters in Regulatory Affairs – Northeastern University (2021-09 – 2023-07)