Shriram Temgire

Background

About Shriram Temgire

I’m a dedicated and detail-oriented Regulatory Affairs Specialist with 2+ years of experience in global clinical trial operations, regulatory submissions, labelling compliance, and document control. My professional journey includes working with top-tier organisations, such as Labcorp Drug Development, and contributing to projects for Johnson & Johnson across the EMEA, NA, APAC, and LATAM regions. In my current role, I manage the full lifecycle of regulatory documentation — from CTMS and TMF management to drug listing submissions, Structured Product Labelling (SPL), and 21 CFR Part 820 promotional material reviews. I collaborate cross-functionally with medical, data management, quality assurance, and legal teams to ensure compliance, resolve data inconsistencies, and maintain audit readiness. I’ve handled real-time troubleshooting, such as retrieving critical documents under tight timelines, resolving AE/SAE mismatches, and aligning labelling components across markets. I’ve actively supported system validation, global change controls, and coordinated regulatory responses — all while maintaining strict adherence to ICH-GCP and internal SOPs. Prior to this, I worked as a Quality Auditor, where I conducted medical record reviews, optimized query resolution workflows, and contributed to audit success by helping the team achieve zero critical observations. Key Skills: Regulatory Documentation & Labeling (SPL, Med Guides, ANDA) Clinical Trial Management Systems (CTMS), Trial Master File (TMF) Medidata Rave, Pharmacovigilance Tools, 21 CFR Part 820 Compliance Global Regulatory Submissions & Drug Listings Cross-Functional Collaboration (QA, Medical, Legal, Clinical Ops) Audit Readiness & Document Change Control I’m passionate about ensuring regulatory accuracy, patient safety, and operational excellence in clinical development. If you’re looking to connect with someone experienced in the intersection of regulatory compliance, clinical data integrity, and global health standards — let’s connect!