Ganesh Harne

About Ganesh Harne

Regulatory Affairs | CMC | RIM | Lifecycle Management | Global SubmissionsCurrently working in CMC on the RIM platform LIQUENT InSight, Calyx 2.0, Viva vault with expertise in global regulatory submissions and product lifecycle management. Experienced in handling event/application creation for NDA, IND, MAA, applications, using Calyx 2.0 and Orion for both Supplement CMC and Administrative Events with an impact on Module 3.CMC Regulatory Submissions (Post Approval)- Event Creation (Variations, Renewals, Transfers)- Change Control Management- Product Detail Set (PDS) Creation & Updates- IND, NDA/MAA, DMF, MAT Documentation- Lifecycle Maintenance Activities- Submission Quality Control & Review- Microsoft Office (Power BI,Excel, Word, PowerPoint)- Cross-Functional Collaboration Trusted by the client as Partner Lead for the team, managing multiple projects with minimal supervision. Skilled in Product Detail Set (PDS) creation and updates, and status tracking for Post-Approval Changes like US-AR, CBE-0, CBE-30, PAS. Maintain 100% quality and regulatory compliance across US, EU (MRP/DCP/National procedures), and MHRA markets. Proficient in generating Submission Report Summaries via SPT, mailbox monitoring, and Power BI Dashboard reporting. Hands-on experience with Reliant Calyx COGNOS, RIM,Orion COGNOS, and managing Global Country Registration Status & NRI queries. Cross-trained in eCTD modules, dossier compilation, post-approval changes, and lifecycle management for EU (Type IA/IB/II, Line Extensions) and US submissions. Familiar with regulatory systems like eDOK, Veeva Vault, and submission/publishing processes.

Experience

1. Regulatory Affairs Associate

   Tata Consultancy Services

   Jan 2023 — Present · Mumbai, IN

   Regulatory Affairs Associate with 3 years of experience in CMC compliance, regulatory submissions, andProduct Detail Sets (PDS) management for EU, UK, US, and Canada markets. Proficient in regulatory agencycommunication and skilled in using industry-standard tools such as Liquent Insight, CALYX, Cognos, and ETQ.Adept at ensuring SOP compliance, managing Module 3 regulatory documents, and contributing to stramlinedregulatory processes.

Education

• Sant Gadge Baba Amravati University, Amravati

  Master of pharmacy , Quality Assurance

• Maharashtra State Board of Secondary and Higher Secondary Education (MSBSHSE)

  Ssc

• Maharashtra State Board of Secondary and Higher Secondary Education (MSBSHSE)

  HSC, Science

• Sant Gadge Baba Amravati University, Amravati

  Bachelor of Pharmacy - BPharm, Pharmacy