Ragahvendra

C

Senior consultant

Continuum India LLP

Feb 2023 - Current (3 years 6 months)

• Led the implementation and maintenance of ISO IDMP data processes, ensuring alignment with SPOR standards and regulatory requirements. • Interpreted IDMP standards, SPOR data models, supporting accurate regulatory data management. • Monitored ISO IDMP and EMA regulatory updates and developed strategic recommendations for clients to ensure timely compliance. • Analyzed regulatory data from multiple systems and mapped product data to SPOR standards for IDMP readiness. • Extracted, validated, and compiled IDMP data fields (SPOR) into structured formats • Collaborated with cross-functional teams across Regulatory Affairs to establish efficient workflows for IDMP activities. • Submitted and managed new term requests to EMA for RMS and OMS upda

G

Lead Associate (Global labeling management)

Genpact Pharmalink

Jun 2020 - Feb 2023 (2 years 9 months)

• Act as Subject Matter Expert (SME) by planning submissions, scheduling workload, and assigning tasks to team members. • Monitor progress through trackers and present work status, risks, and issues in client meetings. • Manage administrative activities including KPI and Reverse KPI preparation. • Implement proposed variations with formatting and QRD template compliance for English PI documents (PI, Annex-A, Annex-C). • Coordinate with EU country affiliates for labeling updates and ensure implementation of all review comments. • Manage linguistic process coordination and submit documents for Day+5 and Day+25 timelines. • Support post-approval labeling activities. • Review and finalise variation classification requests and prepare Module 1 c

Senior Process Associate (Global labeling management)

Freyr Solutions

Jun 2018 - May 2020 (2 years)

• Prepare and update Regional Prescribing Information (RPI) for Rest of World (ROW) submissions including MAA/variation base documents, redline & clean versions, and comparison tables in MS Word. • Perform quality review of labeling documents (PI, Leaflet, IFU) including proofreading, formatting, and alignment with regional templates and client reference guides prior to submission and artwork creation. • Conduct Translation QC for ROW labeling and Patient Package Inserts (PPI) in line with translation QC processes. • Review CCDS documents ensuring proofreading and formatting compliance with client templates and reference guides. • Prepare side-by-side label comparisons (e.g., CCDS vs MAH labels). • Support biosimilar labeling preparation in

Senior Process Associate (Global Regulatory Affairs)

Tata Consultancy Services

Oct 2016 - Mar 2018 (1 year 6 months)

• Perform XEVMPD submissions for EU region using SmPC and PIL labeling documents in compliance with Article 57 guidelines. • Update and maintain product information in EV-Web for EU procedures (MRP, DCP, CP, NP). • Ensure data consistency between EV-Web, labeling documents (SmPC, PIL), and RIMS (Liquent Insight). • Maintain and review Module 3 (CMC) dossier information in RIMS (Liquent Insight). • Raise queries with Local Operating Companies (LOCs) for discrepancies or variations in regulatory documents. • Perform remediation and maintenance of product registration data in RIMS for pharmaceuticals, vaccine and consumer healthcare products. • Support Global Regulatory Affairs teams and regional affiliates to ensure accurate regulatory data m

i

Executive Regulatory Affairs (IDMP)

iMED Global Solution

Jan 2016 - Oct 2016 (10 months)

• Strong understanding of regional regulations, regulatory guidance, and ICH guidelines, with working knowledge of EU regulatory procedures (National, CP, MRP, DCP). • Understanding of IDMP scope and requirements, supporting regulatory data collection, analysis, and maintenance in IDMP data management systems. • Track regulatory data from Connect and update ARIS Register (RIM tool). • Perform data quality gap analysis, data cleanup, and data reconciliation. • Support development teams with Register field definitions and system configuration requirements. • Assess and utilize Register LU / Variation Request modules for regulatory data management. • Provide functional support for Interim IDMP Data Repository development, including EudraVigila

K

Associate

Kinapse India Scientific Pvt. ltd

Nov 2014 - Oct 2015 (1 year)

• Undertake information processing activities with extremely high reliability, high quality and in tight timelines according to standard • Manual recording of terms, EVPRM Creation or any other related activity as per the project requirement • EMA xEVMPD, Validation of EVPRM as per EMA guidelines • MedDRA trained and experience in coding in MedDRA • Good working knowledge of Medical terminology • Involved in effective project management/team management as required

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