Bhamre, PMP Trained, CSM®, CSSE-GB®

● Managing client program, driving delivery ahead of schedule and under budget through strategic resource allocation and stakeholder alignment. ● Responsible for overseeing the creation, review, and maintenance of Clinical Evaluation Reports, PSUR, PMS, and PMCF projects in compliance with regulatory requirements for Patient Monitoring, Physical Examination & Cardiology Devices. Develop and manage project plans for development and updates. Coordinating with cross-functional teams, managing timelines, and ensuring the accuracy and quality of documentation. ● Facilitated Agile ceremonies (Sprint Planning, Stand-ups, Sprint Demos, Sprint Retro) for Cardiac medical device software, IVD software using JIRA tool; tracked velocity, KPIs, RAID log, Risk Register. ● Applied PMI principles to manage scope, quality, cost & quality developed plans, team leadership, and led risk mitigation to ensure regulatory and market readiness ● Managing procurement lifecycle: Purchase Requisitions, Orders, invoices, and payments. Coordinating with finance & suppliers for timely transaction processing. ● Cross-functional Team Coordination: R&D, Clinical, Regulatory, Quality, Marketing, Supply Chain, IT support for flawless execution.

● Project Management: Successfully launched 50+ medical device products in the European market, ensuring patient access by managing and delivering EUMDR labeling, IFU, packaging, and clinical compliance for a top US medical device firm dealing with Catheters, Stents, Guidewires etc. Led diverse onshore-offshore teams. ● Applied PMI principles to manage scope, quality, cost & quality developed plans, team leadership, and led risk mitigation to ensure regulatory and market readiness. ● PFAS, REACH & RoHS: related initiatives focused on regulatory documentation. ● TEDREG - Global Regulatory Intelligence Platform: Instrumental in providing inputs to create a platform for monitoring local and global regulatory information and its impact, offering validated insights to pharma, biotech, and medical device manufacturers. ● Client collaboration: Instrumental in collaborating with clients to understand their needs, creating tailored solutions and strategies to drive growth and profitability, ultimately enhancing client satisfaction, and fostering long-term relationships. ● Managing procurement lifecycle: Purchase Requisitions, Orders, invoices, and payments. Coordinating with finance & suppliers for timely transaction processing. ● Cross-functional Team Coordination: R&D, Clinical, Regulatory, Quality, Marketing, Supply Chain, IT support for flawless execution. ● Business Support: Monitoring and reporting project status, milestones, risks, and budget variances. Managing and coordinating procurement processes, including RFP/RFI.

● Pharmaceutical Labeling, Artwork, and Medical & Scientific Writing for CTD/ACTD dossiers. ● Regulatory Affairs: Authored white papers on EU MDR 745 and IVDR 746, providing insights into regulatory requirements and implications for the industry. ● Scientific Writing: Proficient in utilizing PubMed, Medline, Embase, and Cochrane databases for Nonclinical and Clinical Study report authoring.

● Regulatory Affairs: Managed end-to-end labeling and artwork processes for US and EU projects. Updated and revised client labels (CDS, SmPC/PIL, USPI/PPI/MED-GUIDE/IFU). Managed Structured Product Labeling (SPL) and ensured compliance with regulatory style guides. ● Pharmaceutical Labeling, Artwork, and Medical & Scientific Writing for CTD/ACTD dossiers. ● Scientific Writing: Proficient in utilizing PubMed, Medline, Embase, and Cochrane databases for Nonclinical and Clinical Study report authoring.

● Regulatory Affairs: Managed end-to-end labeling and artwork processes for US and EU projects. Conducted quality control of country reference labels. Updated and revised client labels (CDS, SmPC/PIL, USPI/PPI/MED-GUIDE/IFU). Referenced clinical overviews to support CDS updates. Managed Structured Product Labeling (SPL) and ensured compliance with regulatory style guides.

● Early-Stage Drug Discovery & Translational Research: As a in vivo pharmacologist, I supported evaluation of New Chemical entities (NCEs) for the efficacy in animal models (preclinical) of inflammation. ● I conducted biomarker analysis to elucidate pharmacodynamic effects and mechanism of action, including the quantification of inflammatory markers such as IL-6, TNF-alpha, IL-12, Serum SAA, Serum Triglyceride’s using ELISA technique.

● Early-Stage Drug Discovery & Translational Research: As a in vivo pharmacologist, I supported evaluation of New Chemical entities (NCEs) for the efficacy in animal models (preclinical) of oncology. ● I conducted biomarker analysis to elucidate pharmacodynamic effects and mechanism of action, including the quantification of inflammatory markers such as IL-6, TNF-alpha, CD31, and BDNF using ELISA and immunohistochemistry (IHC) technique. ● I was a Scientific Contributor for Preclinical development of OCID 4681 currently in clinical phase.