Venkatesh Katuri
Hyderabad
Summary
Regulatory information management expert with nearly 12 years in Veeva Vault RIM operations and pharmaceutical data management. Skilled in CMC review, dossier compilation, and registration data management for ANZ, ASEAN, and LATAM markets. Proficient in XEVMPD and IDMP compliance, ensuring global regulatory adherence through data governance and quality monitoring. Adept at managing regulatory systems, process documentation, and stakeholder engagement to drive operational excellence.
Overview
11
11
years of professional experience
Work History
RIM Manager
Bristol Myers Squibb
Hyderabad
12.2023 - Current
- Managed end-to-end support for CCDS labeling events, ensuring regulatory compliance, quality standards, and timely delivery of labeling updates.
- Led quality governance activities by monitoring labeling accuracy, driving corrective actions, and supporting audit readiness and issue resolution.
- Maintained and updated process specific work instructions and JOB Aid consistently.
- Supported internal audits, inspections, and corrective preventive action plans.
- Resolved identified actions within developed areas of expertise effectively.
- Collaborated with global cross-functional stakeholders to resolve escalations, support users, manage health authority queries in Veeva RIM, and track submissions through closure.
Senior Specialist, RCRIM
Merck Specialties Pvt Ltd
Bangalore
06.2022 - 12.2023
- Established relevant metadata in Vault RIM and oversaw submission content plan structure to enhance regulatory compliance.
- Managed planning, tracking, and monitoring of regulatory activities in information management system.
- Collaborated with global regulatory affairs to enhance information management efficiency.
- Created and distributed global CMC change controls, issuing workflows for assessments and submission planning.
- Uploaded health authority correspondence and labeling documents into system with accurate metadata.
- Created health authority queries and tracked closures, sending regular reminders to users to ensure timely resolution.
- Monitored data quality across system objects, sending reminders to users to address and correct identified issues.
- Initiated communication with users to address inquiries and provide support. upon identifying data quality issues, ensuring prompt resolution.
Regulatory Specialist, RRDM Level 1(9b)
GSK India Global Services Pvt. Ltd.
Bangalore
09.2018 - 06.2022
- Ensure that GSK product registration information is maintained to a standard appropriate to support critical regulated processes including Pharmacovigilance and GMP-compliant product supply.
- Coordinated with EMA for SmPC updates and facilitated data submission in EV Web portal, enhancing regulatory alignment.
- Manage updates and maintain data accuracy in xEVMPD, PLM and OPAL.
- Executed substance and MEDDRA remediation activities within xEVMPD, ensuring compliance with regulatory standards.
- Creation/updation of MA, AMP, PMP specifications in Product life cycle management tool (PLM).
- Participated in training and developed documentation to support team knowledge and compliance efforts.
Assistant Manager
Cipla.
Mumbai
11.2017 - 08.2018
- Compiled and reviewed registration dossier (M1 - M5) in CTD format, ensuring compliance with Australia and New Zealand guidelines.
- Provided high-quality responses to agency queries within established timelines.
- Updated registration files and databases regularly to ensure accuracy and reflect current registration and post-approval changes.
- Maintained registered and commercialized products, preparing RA tables and reviewing artwork/SPMS to support regulatory compliance.
- Prepared packages for clone applications, TGA GMP clearance, and variation submissions.
- Facilitated interdepartmental collaboration to streamline regulatory processes and enhance coordination within international regulatory operations.
Senior Associate
Mylan Laboratories Ltd
Bangalore
09.2015 - 10.2017
- Ensure timely response to deficiencies received from regulatory agencies to secure approval.
- Managed lifecycle of filed/approved dossiers, including product change history and renewal/re-registration.
- Ensured consistency and adequacy of submission documents to meet current regulatory requirements for ASEAN, LATAM, and North African countries.
- Collaborated cross-functionally with R&D, project management, and commercial team as regulatory subject matter expert to ensure regulatory compliance.
Education
Master's - Pharmacy
NIPER
Kolkata08-2014
PG Diploma - Regulatory affairs
BII
Noida01-2014
Bachelor’s - Pharmacy
Chalapathi Pharmacy College
Guntur07-2012
Skills
- Regulatory submissions
- Regulatory compliance
- Regulatory data management
- Data Governance
- Data quality
- Data Stewardship
- Veeva Vault
Languages
- English
- Hindi
- Telugu
Hobbies and Interests
- Playing Badminton and Cricket
- Travelling
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge.
Timeline
RIM Manager
Bristol Myers Squibb
12.2023 - Current
Senior Specialist, RCRIM
Merck Specialties Pvt Ltd
06.2022 - 12.2023
Regulatory Specialist, RRDM Level 1(9b)
GSK India Global Services Pvt. Ltd.
09.2018 - 06.2022
Assistant Manager
Cipla.
11.2017 - 08.2018
Senior Associate
Mylan Laboratories Ltd
09.2015 - 10.2017
Master's - Pharmacy
NIPER
PG Diploma - Regulatory affairs
BII
Bachelor’s - Pharmacy
Chalapathi Pharmacy College