Regulatory Affairs Associate

Mohammed Nayeem Uddin Qureshi

Regulatory Affairs Associate Regulatory Operations Quality Compliance

NY, USA +1-872-***-**** ******************@*****.*** LinkedIn

SUMMARY

Regulatory Affairs and Quality Compliance professional with nearly 6 years of pharmaceutical experience

supporting submissions, eCTD readiness, labeling updates, product changes, GMP documentation, CAPA,

deviations, and inspection readiness across U.S. and global operations. Proven record improving iling

accuracy, submission timeliness, audit preparedness, document control, and coordination with Quality,

Manufacturing, Supply Chain, and Medical Affairs teams. Hands-on experience with Veeva Vault, EDMS,

reporting dashboards, training compliance, and regulatory records management. Well aligned for Entry-

Level to Early Mid-Level Regulatory Affairs, Regulatory Operations, Labeling, Documentation, Quality

Compliance, and GMP-focused opportunities in the United States market.

PROFESSIONAL EXPERIENCE

Regulatory Affairs Associate Jan 2025 - Present NY, USA

Johnson & Johnson

? Increased on-time submission delivery 24% by managing iling calendars, approval checkpoints, and

renewal schedules for supplements, annual reports, and lifecycle commitments across assigned

products portfolios.

? Improved irst-pass iling accuracy 31% by reviewing source documents, metadata, hyperlinks, and

version history before eCTD publishing and inal submission release to authorities.

? Reduced internal review cycles 27% through structured checklists, ownership timelines, and follow-up

coordination with Quality, Manufacturing, Supply Chain, and Medical Affairs teams companywide.

? Prevented eight launch delays by reconciling labeling text, artwork components, carton claims, and

package inserts against approved regulatory records before commercial release.

? Shortened authority response turnaround 22% by preparing de iciency replies, supporting data, and

status updates within committed regulatory deadlines across active submissions portfolios.

? Improved document retrieval speed 48% by reorganizing Veeva Vault indexing, archive naming

standards, and controlled repository access for inspections and audits.

? Increased leadership visibility 35% through dashboards tracking due dates, workload capacity,

milestone risks, and pending actions across active programs organizationwide consistently.

? Accelerated onboarding readiness 40% by training new hires on SOPs, templates, submission

standards, and internal regulatory procedures across business functions successfully.

Quality Compliance Analyst Aug 2020 - Dec 2024 India

P izer

? Reduced documentation errors 29% by strengthening review controls across SOPs, batch records,

speci ications, logs, and controlled manufacturing documents supporting regulated operations daily.

? Improved batch release readiness 26% through detailed checks of signatures, calculations,

reconciliations, and data integrity before quality disposition across manufacturing operations

consistently.

? Closed deviation records 33% faster by coordinating investigations, evidence collection, corrective

actions, and timeline follow-up across production and quality functions ef iciently.

? Lowered repeat indings 21% through CAPA ownership tracking, effectiveness checks, overdue

escalation, and closure governance across monitored processes during annual reviews.

? Increased procedural compliance 24% by conducting periodic document reviews and updating

obsolete instructions after approved operational changes across departments companywide

consistently.

? Strengthened inspection readiness 37% by preparing evidence packages, retrieving records quickly,

and tracking remediation actions during internal and external audits successfully.

? Raised training completion rates 32% through overdue assignment monitoring, manager reminders,

and weekly compliance reporting across production, warehouse, and quality departments consistently.

? Improved management reporting 28% by producing dashboards covering deviations, CAPA aging,

training status, audit trends, and quality metrics for leadership reviews monthly.

TECHNICAL SKILLS

Regulatory Affairs: FDA Submissions, eCTD Readiness, Submission Planning, Annual Reports, Renewals,

Post-Approval Changes, Lifecycle Maintenance, Regulatory Documentation, Health Authority Responses,

Filing Timelines, Product Registrations.

Labeling & Documentation: Labeling Compliance, Artwork Review, Carton Text Review, Package Inserts,

Claims Veri ication, Version Control, Controlled Documents, Records Management, Document

Reconciliation, Change Documentation.

Quality & Compliance: cGMP, GMP, CAPA, Deviations, Change Control, SOP Management, Audit Readiness,

Inspection Support, Training Compliance, Data Integrity, Root Cause Analysis, Corrective Actions.

Systems & Tools: Veeva Vault, EDMS, SharePoint, Microsoft Excel, Word, PowerPoint, Dashboard

Reporting, Metrics Reporting, Submission Trackers.

Operations: Cross-Functional Coordination, Manufacturing Support, Supply Chain Coordination,

Stakeholder Communication, Timeline Management, Risk Tracking, Process Improvement, Onboarding

Support.

PROJECTS

Analytical Method Development & Validation B. Pharm Thesis

? Designed and validated an HPLC method for quantitative drug analysis following ICH Q2(R1)

requirements for accuracy, precision, linearity, speci icity, and robustness.

? Investigated chromatographic conditions including mobile phase composition, low rate, and retention

behavior to improve peak resolution, reproducibility, and testing ef iciency during method

optimization.

? Authored validation protocols, raw data summaries, deviation notes, and inal reports supporting

traceable records, controlled documentation, and inspection-ready laboratory practices.

? Executed calibration checks, sample preparation, system suitability testing, and result review while

maintaining disciplined laboratory records and data integrity standards.

EDUCATION

Masters in public Health Administration Aug 2025 IN, USA

Indiana Wesleyan University

Bachelors of Science in Pharmacy Sep 2020 India

Osmania University

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