Teena George
Summary
Dedicated and results-oriented Regulatory Affairs Senior Associate with three years of hands-on experience in ensuring the meticulous preparation and submission readiness of regulatory documents. Possesses a strong understanding of regulatory requirements, document management systems, and the details of document submissions to health authorities. A reliable professional committed to maintaining the highest standards of quality and accuracy in regulatory submissions.
Overview
3
3
years of professional experience
Work History
Senior Associate - Document and Submission Support
Merck Specialities Pvt Ltd
09.2020 - 12.2023
- Played pivotal role in document submission and support for regulatory submissions to Health Authorities.
- Ensured adherence to regulatory agency requirements by maintaining high standards for formatting authored documents for inclusion in regulatory submissions.
- Collaborated closely with Authors, Global Regulatory Leads (GRL), Subject Matter Experts (SMRA), and Project Management Regulatory Affairs (PMRA) teams to ensure document submission readiness activities.
- Created and updated Virtual Document Binders and Report Level Content Plans ('Virtual Dossier') for comprehensive regulatory submissions.
- Conducted report level publishing for various document types, including patient safety, clinical, and nonclinical documents.
- Provided crucial support to stakeholders by managing literature needs, including ordering from the Scientific Library, checking for copyrights, formatting, uploading, and obtaining approvals.
- Acted as the point of contact for addressing all eDMS-related queries, offering efficient solutions to stakeholders.
- Managed and maintained templates within the VEEVA system, ensuring consistency and compliance with regulatory standards.
- Offered backend support for updating submission content plans, ensuring accurate and timely submissions to Health Authorities.
- Acted as a power user for submission applications
- Assured the alignment of submission documentation with registration needs and timelines, contributing to successful regulatory approvals.
Education
Master of Pharmacy - Pharmaceutical Regulatory Affairs
Nitte Deemed To Be University
Mangalore, Karnataka, India2020
Bachelor of Pharmacy -
Kerala University of Health Sciences (KUHS)
Thrissur, Kerala, India2018
Skills
Software knowledge on:
- Veeva Vault
- Eldorado Toolbar
- eCTD Manager
- Lorenz Validator
- CARA
- ISI Toolbox
- RLP Manager
- Adobe Acrobat
Document Management
Submission Management
Compliance Monitoring
Communication and Coordination
Timeline
Senior Associate - Document and Submission Support
Merck Specialities Pvt Ltd
09.2020 - 12.2023
Master of Pharmacy - Pharmaceutical Regulatory Affairs
Nitte Deemed To Be University
Bachelor of Pharmacy -
Kerala University of Health Sciences (KUHS)
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