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
Bangalore, Karnataka, India
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
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Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group<ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. Supporting quality assurance team for DMF submission.</li><li>14. Executing and supervising training, validation, qualification and calibrations protocols.</li><li>15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.</li><li>CGMP:</li><li>1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.</li><li>2. Making sure all the documents and checklist are verified before and after manufacturing.</li><li>3. Ensuring retention and destruction of records are maintained in a department.</li><li>4. Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group
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