Chetana Bhajantri
Lead Consultant
Bengaluru,KA
Summary
Seasoned collaborator with a proven ability to meet diverse needs, improve processes, and exceed expectations within team environments. Recognized for strong communication and task prioritization skills, complemented by a comprehensive background in analyzing complex data to drive strategic initiatives. Expertise in enhancing operational efficiency and supporting decision-making through detailed analysis, leveraging data modeling and process improvement techniques. A dedicated team player focused on achieving results and adapting to dynamic business landscapes, consistently identifying inefficiencies and recommending practical solutions through critical thinking.
Overview
9
9
years of professional experience
5
5
Certifications
Work History
Business Analyst, Regulatory Information Management System
Insight Global- Evergreen, Hyderabad
12.2024 - Current
- I am presently working as a Consultant at Insight Global - Evergreen, Hyderabad (for Daiichi Sankyo, with a client role as Lead Business Analyst) for the Regulatory Information Management system, to help the clients extemporize their next steps in their digital transformation journey, with the responsibilities below:
- Spearheaded the business analysis function for the Regulatory Information Management system, defining user requirements and translating business cases into vendor-ready software configurations.
- Performed gap analysis between existing systems or processes and desired state, identifying areas for improvement or enhancement.
- Managed the full project lifecycle, from scoping to successful launch, including monitoring milestones and assessing problem resolution for key projects.
- Provided business process expertise and governed SOPs across cross-functional teams (OCM, Business Function, Validation, Training) to ensure successful system adoption.
- Developed and maintained comprehensive documentation for regulatory processes, ensuring compliance with industry standards, and improving operational efficiency, such as SOPs, WIs, and User Guides.
- Analyzed complex datasets to identify trends and insights, resulting in enhanced decision-making and strategic planning for regulatory initiatives.
- Led training sessions for staff on regulatory compliance and system usage, fostering a culture of continuous improvement and knowledge sharing.
- Stakeholder Engagement and Collaboration: Liaise with internal and external stakeholders (RA, Clinical, CMC, QA, PV, Manufacturing, etc.). To gather and finalize documents for submission.
- Boosted team productivity by introducing agile methodologies, fostering more dynamic and responsive work environment.
- Configured and deployed Veeva Vault modules, ensuring GxP compliance and adherence to 21 CFR Part 11 standards, resulting in an improvement in regulatory compliance efficiency.
Lead Consultant, Regulatory Information Management System
Genpact Pvt Ltd, Bengaluru
11.2022 - 12.2024
- Demonstrated expertise in requirement gathering, translating complex needs into user requirement documents, and participating in system customization workshops for Veeva Vault.
- Developed and reviewed Veeva Vault training materials, including eLearning modules using the Articulate 360 application, to support data entry guidance and system adoption for end users.
- Led data quality initiatives, including data cleansing and IDMP data management (P, O, and R data) activities to ensure compliance with regulatory standards.
- Developed and executed training programs for team members, resulting in improved proficiency and reduced onboarding time.
- Led the implementation of regulatory information management systems, enhancing compliance and operational efficiency across multiple projects.
- Streamlined data management processes, significantly reducing discrepancies and ensuring accurate reporting for regulatory submissions.
- Collaborated with cross-functional teams to identify system improvements, fostering a culture of continuous enhancement and innovation.
Specialist I- RIMS
Freyr Solutions Pvt Ltd, Hyderabad
06.2021 - 11.2022
- At Freyr Solutions (for Reckitt Information Technology Business Analyst – LSRIMS Senior Consultant), the Department of RSS as Specialist I - RIMS.
- Collaborated with IT to refine RIMS tools, increasing user accessibility and enhancing data management capabilities.
- Developing the proposal(s) by owning parts of the proposal document, and by giving inputs in solution design based on areas of expertise.
- Involved in the successful management of Go-Live and HyperCare activities, and assisting with Business As Is activities. Managing the change requests in the RB_Assist portal.
- Analyzed regulatory compliance data to enhance reporting accuracy, streamlining processes and improving team efficiency.
- Led the implementation of risk assessment strategies, resulting in improved operational effectiveness and reduced compliance issues.
- Developed training materials for new staff, fostering a comprehensive understanding of regulatory requirements and processes.
Consultant in the Department of Regulatory Process & Compliance (Business Services at Aris Global)
Aris Global Software Pvt Ltd, Mysuru
06.2017 - 06.2021
- Worked as a consultant in the Department of Regulatory Process and Compliance (Business Services at Aris Global), and managed a team with the responsibilities below:
- Analyzed and optimized the customer data according to the quality standards to identify DQ (Data Quality) issues, and conducted CRUD analysis in line with customer business processes.
- Analyzed and optimized the customer data according to the quality standards currently defined for IDMP submissions for customers like Astellas, AstraZeneca.
- Involved in xEVMPD submission projects for the peer review of regulatory data for various clients, following the existing EMA XEVMPD submission guidelines.
- Experienced in working with Documentum Management systems, such as Documentum, SharePoint, and Veeva Vault.
- SOP (Standard Operating Procedures) and WI (Work Instructions) development for various regulatory, safety, and medical affairs processes that are compliant with regulatory guidelines for customers like Astellas, AstraZeneca, Galderma, Vifor, etc.
- IDMP Data Readiness Assessments, including mapping of ISO IDMP data elements to source systems.
- Worked on creating and validating Pharmaceutical and Medical Device Industry Standard Processes, such as Marketing Authorization, Renewal, Variations, etc.
- Worked on creating training materials, eLearning materials for the Regulatory Information Management System for US, EU, and Japan-based customers in line with the customer business processes. Conducting end-user training, train-the-trainer sessions also train the key users.
- Streamlined compliance processes by implementing regulatory frameworks, improving operational efficiency and enhancing adherence to industry standards.
- Led cross-functional teams to assess and mitigate compliance risks, resulting in improved organizational compliance awareness and reduced regulatory breaches.
- Developed and executed training programs on regulatory compliance, fostering a culture of accountability and ensuring staff adherence to updated policies.
- Analyzed regulatory changes and communicated implications to stakeholders, enabling timely adjustments to business operations and maintaining compliance integrity.
Project Intern, Raw Materials Department
Anthem Bio-Sciences Pvt Ltd, Bengaluru
09.2016 - 01.2017
- Conducted thorough analysis of raw material specifications, ensuring compliance with industry standards and reducing discrepancies.
- Collaborated with cross-functional teams to address material quality issues, leading to improved product performance and reduced waste.
Education
M.Tech - Bio-chemical Engineering
BMS College of Engineering
Bengaluru03.2016
B.E - Bio-technology
Bapuji Institute of Engineering and Technological
Davanagere05.2014
Skills
Veeva Vault RIM, LifeSphere Regulatory (LSRIMS), Register, agXchange RSM, DMS and regulatory tracking systems
Accomplishments
- Developed new generation product for IDMP submissions based on ISO IDMP Standards.
- Successfully handled multiple versions of the product of Regulatory Tracking System implementations for various US, EU & Japan based customers.
- Knowledge on EMA Guidelines, different types of approval procedures in European countries.
- Worked on EVMPD Regulatory Submissions and Variations Submissions for major clients of European region through regulatory management tools for submissions.
- Conducted ‘Train the trainer', ‘Key User Training' and ‘End User trainings' on-site as well as virtual trainings for RIMS applications.
Certification
Generative AI for Business Analysts Course LinkedIn By: Vincent Mirabelli
Disclaimer
I hereby declare that the information provided above is true to the best of my knowledge.
Place: Bengaluru
(Chetana Bhajantri)
Timeline
Business Analyst, Regulatory Information Management System
Insight Global- Evergreen, Hyderabad
12.2024 - Current
Lead Consultant, Regulatory Information Management System
Genpact Pvt Ltd, Bengaluru
11.2022 - 12.2024
Specialist I- RIMS
Freyr Solutions Pvt Ltd, Hyderabad
06.2021 - 11.2022
Consultant in the Department of Regulatory Process & Compliance (Business Services at Aris Global)
Aris Global Software Pvt Ltd, Mysuru
06.2017 - 06.2021
Project Intern, Raw Materials Department
Anthem Bio-Sciences Pvt Ltd, Bengaluru
09.2016 - 01.2017
B.E - Bio-technology
Bapuji Institute of Engineering and Technological
M.Tech - Bio-chemical Engineering
BMS College of Engineering