Ruchira Atkari
Allen
Summary
Experienced regulatory affairs professional specializing in oncology drug regulatory submissions. Skilled in navigating the US regulatory affairs product life cycle, including ANDA, module 1, amendments, supplements, FDA deficiency responses, and annual reports. Proficient in preparing dossiers for electronic submissions and publishing, with expertise in electronic document management systems. Background as a technical document coordinator with CRO, involved in preparation and review of PK and BA/BE study protocols, case report forms, informed consent, study protocols, and Clinical study reports (ICH-E3 compliance).
Overview
3
3
years of professional experience
1
1
Certification
Work History
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
- Drafting Regulatory Legal Documents: Authored country-specific regulatory legal documents for Clinical Study Reports (CSRs), including but not limited to Power of Authorization, Power of Attorney, Cover Letters, Letters of Authorization, Warehouse Warranty Letters, and Supply Chain Letters, ensuring alignment with local requirements.
- Document Review and Execution: Reviewed and facilitated the execution of legal documents (e.g., Power of Attorney, Letters of Authorization) with internal teams and external partners. Managed the notarization, legalization, tracking, and shipment of finalized documents.
- Cross-Regional Regulatory Coordination: Collaborated with regional leads across Asia-Pacific (AP), Latin America (LA), and Middle East–West Asia (MEWA) to clarify regulatory requirements, obtain critical documentation, and ensure adherence to local submission timelines.
- Regulatory Tools and Systems: Proficient in handling regulatory software tools including ISI Toolbox, ISI Publisher, and eCTD Xpress, for dossier preparation and submission management.
- Document Tracking and Issue Resolution: Monitored documentation workflows to ensure timely completion and delivery to Local Operating Companies (LOCs). Proactively resolved any issues related to delays, missing documents, or shipment concerns.
- Electronic Systems Management: Retrieved submitted documents from GRAIL and uploaded them to ERIS (Electronic Regulatory Information System) for EDMS number generation. Maintained submission records through SharePoint and ERIS for audit readiness.
- Regulatory Submission Preparation: Supported the preparation of major regulatory submissions including BLA, NDA, and MAA dossiers. Assisted in the management of labeling deviations and ensured compliance with evolving health authority requirements.
- Project & Query Tracking: Tracked project deliverables using SharePoint-based Excel trackers, monitored overall project status, and maintained updated records of Health Authority (HA) queries, deadlines, and resolution status.
- Regulatory Support and Reporting: Provided comprehensive regulatory support to Regulatory Leaders and Senior Regulatory Associates within the RSI Regional Regulatory Affairs team. Reported directly to the Director for AP & LA, Global Regulatory Affairs (GRA) and collaborated closely with the global regulatory team.
Education
MS - Regulatory Affairs For Drug, Biologics And Medical Devices
Northeastern University
Boston, MA04.2016
Bachelor of Pharmacy -
University of Mumbai
05.2013
Skills
- Skilled in using SharePoint and MS Project
- Experience with ANDA, NDA, BLA submissions
- ICH-GCP/GMP regulatory knowledge
- eCTD dossier preparation
- Experience with clinical trial reporting guidelines
- Experienced with ERIS, GRAIL, and ISI Toolbox
- Development of protocols and CSRs for studies
- Project coordination
- Regulatory inquiry management
Certification
Certified Pharmacy Technician
Certified Pharmacovigilance Professional
Timeline
Regulatory Document Officer
Raptim research Ltd.
04.2019 - 11.2019
Regulatory Document Coordinator
Janssen Pharmaceuticals, Inc.
09.2016 - 10.2017
MS - Regulatory Affairs For Drug, Biologics And Medical Devices
Northeastern University
Bachelor of Pharmacy -
University of Mumbai
Similar Profiles
Suraj BabarSuraj Babar
Assistant Manager at Raptim Research Pvt. Ltd.Assistant Manager at Raptim Research Pvt. Ltd.
Anoma KambleAnoma Kamble
Medical Writer at Raptim Research Private LimitedMedical Writer at Raptim Research Private Limited
Sikandar JagirdarSikandar Jagirdar
Assistant Manager-Quality Assurance at Raptim Research PVT LTDAssistant Manager-Quality Assurance at Raptim Research PVT LTD
Emily ThomasEmily Thomas
Dance Teacher/Director at Red Door Dance AcademyDance Teacher/Director at Red Door Dance Academy
Bruna CondrenBruna Condren
Cultural Exchange Childcare & Personal Development at Cultural Care USACultural Exchange Childcare & Personal Development at Cultural Care USA