Summary
Overview
Work History
Education
Skills
Websites
Certification
Timeline
Generic
Ruchira Atkari

Ruchira Atkari

Allen

Summary

Experienced Regulatory Affairs and Document Management Specialist with a strong background in organizing, formatting, and maintaining regulatory and compliance-related documentation. Proficient in Adobe Acrobat, Microsoft Office Suite, and electronic document management systems. Demonstrated expertise in SOPs, COAs, training materials, and clinical documents in compliance with ICH-GCP, GMP, and regulatory standards. Adept at cross-functional collaboration with Quality, Operations, and HR teams to ensure document readiness, accuracy, and audit compliance.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Pharmacy Technician

Texas Star Pharmacy
05.2025 - Current
  • Ordered medicines daily to replenish stock and increase inventory in anticipation of need.
  • Restocked pharmacy shelves with current merchandise to drive consistent peripheral sales.
  • Counted and labeled prescriptions with correct item and quantity.
  • Calculated dosage, filled prescriptions, and prepared prescription labels with absolute accuracy.
  • Entered and processed patients' prescriptions into internal system.

Regulatory Document Officer

Raptim research Ltd.
04.2019 - 11.2019
  • Prepared and reviewed Clinical Study Reports (CSRs) in compliance with ICH-E3 guidelines for pharmacokinetic (PK) and bioavailability/bioequivalence (BA/BE) studies.
  • Developed and reviewed CDISC-compliant datasets in alignment with regulatory requirements for the clinical data section.
  • Authored and critically reviewed the clinical section of eCTD dossiers, ensuring submission readiness and regulatory compliance.
  • Drafted and reviewed study protocols for PK and BA/BE studies, including essential study documentation such as Informed Consent Forms (ICFs) and Case Report Forms (CRFs).
  • Coordinated with Institutional Ethics Committees (IECs) for the submission and approval of study protocols and associated documentation.
  • Collaborated with sponsors to address clinical and regulatory queries, ensuring timely and accurate responses.
  • Conducted comprehensive literature searches to support sample size estimation, pharmacokinetic analysis, and safety evaluations.

Regulatory Document Coordinator

Janssen Pharmaceuticals, Inc.
09.2016 - 10.2017
  • Regulatory Document Drafting & Formatting: Authored and formatted a wide range of regulatory and compliance-related documents—including Power of Authorization, Power of Attorney, Cover Letters, Letters of Authorization, and Supply Chain Letters—to support Clinical Study Reports (CSRs), ensuring accuracy and adherence to country-specific guidelines.Oversaw the organization, cataloging, and maintenance of a wide range of controlled documents, including manuals, Standard Operating Procedures (SOPs), batch records, training materials, and compliance-related records such as Certificates of Analysis (COAs), ensuring systematic storage and easy retrieval.
  • Document Review, Execution & Tracking: Coordinated document execution with internal stakeholders and external partners. Oversaw notarization, legalization, and accurate version tracking of finalized documents, maintaining organized records for audit readiness and regulatory compliance.
  • Cross-Functional & Global Collaboration: Worked closely with regional regulatory leads across APAC, LATAM, and MEWA to collect, organize, and manage required documentation in alignment with local submission standards and timelines.
  • Tools & Systems Expertise: Utilized regulatory and document management systems such as ISI Toolbox, ISI Publisher, and eCTD Xpress to compile, format, and prepare submission-ready dossiers and maintain structured documentation workflows.

Education

MS - Regulatory Affairs For Drug, Biologics And Medical Devices

Northeastern University
04.2016

Bachelor of Pharmacy -

University of Mumbai
05.2013

Skills

  • Document management expertise
  • Adobe and Microsoft software skills
  • Proficient in Microsoft Excel, PowerPoint, Outlook, and Teams
  • Versioning and documentation oversight
  • eCTD preparation expertise
  • SOP documentation and review
  • COA documentation expertise
  • Record retention management
  • Document formatting expertise
  • Experience with compliance submissions

Certification

Certified Pharmacy Technician

Certified Pharmacovigilance Professional

Timeline

Pharmacy Technician

Texas Star Pharmacy
05.2025 - Current

Regulatory Document Officer

Raptim research Ltd.
04.2019 - 11.2019

Regulatory Document Coordinator

Janssen Pharmaceuticals, Inc.
09.2016 - 10.2017

Bachelor of Pharmacy -

University of Mumbai

MS - Regulatory Affairs For Drug, Biologics And Medical Devices

Northeastern University

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