Srikanth Amalladinne
Product Owner - Digital Regulatory Platform
Hyderabad,TG
Summary
Product Owner and RIM Lead with proven experience delivering end-to-end Veeva Vault RIMS implementations. Led system configuration, integrations, data migration, and global change management to deliver a compliant, fit-for-purpose regulatory platform. Acted as the key liaison between business and technical teams, translating regulatory and user needs into prioritized product features, user stories, and acceptance criteria. Drove data quality, user adoption, and compliance improvements through agile delivery, stakeholder communication, and continuous product value measurement.
Overview
20
20
years of professional experience
4
4
Certifications
5
5
Languages
Work History
Product Owner
Opella
04.2025 - Current
- Spearheaded the end-to-end implementation of the Regulatory Information Management System (RIMS) using Veeva Vault, aligning system capabilities with Opella’s regulatory and business requirements.
- Led organizational change management initiatives to ensure smooth adoption of the new RIMS platform across global teams.
- Directed system configuration and customization, ensuring the solution was tailored to meet complex regulatory workflows and compliance standards.
- Oversaw seamless integration of RIMS with upstream and downstream systems, enhancing data flow and operational efficiency.
- Managed the data migration strategy, ensuring accurate and secure transfer of legacy regulatory data into the new system.
- Delivered a fit-for-purpose RIMS solution by collaborating with cross-functional stakeholders, gathering requirements, and translating them into actionable product features.
- Acted as the primary liaison between business users and technical teams, ensuring alignment on product vision, priorities, and delivery timelines.
Regulatory Systems and Metrics Analyst
Haleon
07.2022 - 04.2025
- Delivered measurable improvements in data quality, user experience, and regulatory compliance by driving targeted system and process enhancements
- Aligned stakeholders and development teams around a clear product vision, accelerating decision‑making and value‑focused delivery
- Enabled high‑quality, on‑time releases by translating requirements into prioritized backlog items, user stories, and acceptance criteria while actively leading Scrum ceremonies
- Increased product adoption and value realization by supporting RIMS documentation, achieving sprint goals consistently, and leveraging user feedback to guide ongoing improvements
Regulatory System and Metrics Analyst
GSK Consumer Healthcare India
10.2019 - 04.2025
- Partnership with DevOps group in developing Regulatory Veeva Vault RIMS system up-to date with latest enhancements
- Mentoring India Systems Team (Group of 13)
- Interacting with Cross functional Business Stake Holders in liase with their Business Processes within RIMS
- Providing Regulatory Veeva Vault trainings to Cross Functional SMEs
- Support in Writing/Updating the New/Existing Quick Reference Guide(s) for RIMS (Veeva Regulatory Vault)
- Creating User Stories in JIRA and participating in the below key discussions: Product Increment Planning Workshop, Daily Meetings, Backlog Refinement Sessions, Sprint Planning, Sprint Review, Retrospective Discussions
Associate Manager
Celegence
02.2019 - 10.2019
- Regulatory Business SME for Novartis Training workstream project
- Defining the Training Project plan, project charter, Training strategy, Training Development
- Responsible for using and updating RA systems like Regulatory Information Management System (RIMS), Document or Content Management System and eCTD Submissions
- Manage various activities under product lifecycle management (Registrations, Variations, Renewal submissions)
- Preparation of User manuals, training slides, best practices, process flows, FAQs for RIMS application
- Support Implementation of Regulatory Affairs systems as per Client requirements
Deputy Manager
Pfizer
04.2016 - 01.2019
- Led Centralized Data Management (CDM) for APAC & EME markets as Cluster Lead within Regulatory Information Management Systems (RIMS), managing a team of 10 data and senior data associates.
- Partnered with Global Process and Compliance teams to design, implement, and onboard markets to a Single Channel of Communication (SCC) model, ensuring streamlined regulatory workflows.
- Oversaw workload planning, assignment, and monitoring, collaborating closely with regional markets across APAC & EME to ensure timely and compliant regulatory data delivery.
- Reviewed and interpreted regulatory data and dossiers, ensuring accurate population of RIMS tools in alignment with SOPs, business process documentation, and regulatory standards.
- Ensured quality control, regulatory compliance, and team enablement by delivering appropriate training, enforcing SOP adherence, and maintaining system and data quality standards.
Regulatory Operations Manager
Freyr Solutions
07.2014 - 04.2016
- Reported to the Global Head of Regulatory Operations & Compliance, supporting Novartis OTC Division as a Regulatory Information Management (RIM) Specialist – Systems & Submissions.
- Supported global regulatory submissions by managing drug product information, regulatory events, and delivering technical and development data to meet compliance objectives.
- Liaised with internal and external regulatory affairs stakeholders to ensure accurate, high‑quality data delivery in compliance with FDA, European, Canadian, and Asian regulatory guidelines.
- Analyzed, updated, and validated regulatory data across RIM systems to resolve data inaccuracies, maintain data integrity, and ensure ongoing accuracy of regulatory information.
- Coordinated systems integration and regulatory data updates across multiple platforms (OTCDocs – Documentum D2, Register – ArisGlobal, TrackWise – Sparta), while producing training materials and promoting standardized regulatory processes.
Technical Consultant
Wipro technologies
04.2013 - 07.2014
- Provided L1/L2 technical support for end users by troubleshooting application, server, network, and submission issues, including log analysis, Active Directory access, and performance monitoring.
- Managed system operations and maintenance across Production, Validation, and Development environments, including IQ execution, hotfix installations, user access/security administration, and server health monitoring.
- Collaborated closely with vendors and global help desk teams to resolve critical incidents, track issues, implement upgrades, maintain SOPs/work instructions, and conduct troubleshooting via WebEx/teleconferences.
Technical Regulatory Operations - Business Administrator II
Novartis
09.2010 - 03.2013
- Manage the activities of the Business Administrators for systems used by DRA, e.g. REDI, eCTDXPress,ISIPublisher, CoreDossier and DRASA.
- Collaborate with respective DRA Ops groups in BS, the US and Japan for global strategy and planning.
- Maintain a current knowledge of Health Authority requirements for electronic submissions in order to recommend changes to IT systems and business processes.
- Collaborate and coordinate with other line functions plans for upgrades of applications or IT environment.
Team Developer
BA Continuum Solutions Private Limited
12.2006 - 08.2010
- Provided technical support for the Banking related Citrix applications like Ruby, Sapphire.
- Worked as a System Administrator for the Citrix applications.
- Managed a team size of 40 members as an assistant team leader.
Data Processing Executive
First Indian Corporation Private Limited
01.2006 - 11.2006
- Providing Technical Support to Mortgage Tools.
- Verification and Quality check for US mortgage properties documents.
Education
Master of Science (M.Sc.) - Computer Science
Sri Krishnadevaraya University
01-2005
Bachelor of Science - BS - Computer Science
Sri Krishnadevaraya University
01-2003
Skills
Scrum
product owner
Agile Methodologies
Product backlog management
Release planning
Teamwork and collaboration
Team building
Certification
LifeShereRegulatory_5.0_Keyuser Training
Timeline
Product Owner
Opella
04.2025 - Current
Registered Product Owner by Scrum Inc
10-2023
Registered Scrum Master
10-2023
Regulatory Systems and Metrics Analyst
Haleon
07.2022 - 04.2025
Regulatory System and Metrics Analyst
GSK Consumer Healthcare India
10.2019 - 04.2025
Associate Manager
Celegence
02.2019 - 10.2019
Deputy Manager
Pfizer
04.2016 - 01.2019
Regulatory Operations Manager
Freyr Solutions
07.2014 - 04.2016
Technical Consultant
Wipro technologies
04.2013 - 07.2014
Technical Regulatory Operations - Business Administrator II
Novartis
09.2010 - 03.2013
Team Developer
BA Continuum Solutions Private Limited
12.2006 - 08.2010
Data Processing Executive
First Indian Corporation Private Limited
01.2006 - 11.2006
Bachelor of Science - BS - Computer Science
Sri Krishnadevaraya University
Master of Science (M.Sc.) - Computer Science
Sri Krishnadevaraya University