Anand Kharade

[email protected] • +91 9619136688 • 6/10, Mahalaxmi Mansion, K.M. Zhaveri Marg, Bhuleshwar Road, Mumbai – 400004
LinkedIn: https://www.linkedin.com/in/dr-anand-kharade-gaipc%E2%84%A2-cpefpc%E2%84%A2-mima-47851471/ • GitHub: https://github.com/akharadejaro-sys

PROFESSIONAL SUMMARY

I am an AI-Powered Business Analyst and DBA-qualified professional with expertise in Life Sciences, Regulatory Affairs, Pharmacovigilance, Veeva CRM, Regulatory Intelligence, Data Analytics, and Digital Transformation. I specialize in leveraging Generative AI, AI Agents, and AI-augmented Business Analysis to enhance requirement discovery, stakeholder collaboration, process optimization, and data-driven decision-making. With strong experience in regulatory compliance, business process improvement, and enterprise transformation initiatives, I help organizations deliver innovative, compliant, and value-driven solutions while driving Responsible AI adoption. 🧠 Business Analysis Soft Skills: Analytical Thinking | Communication | Critical Thinking | Problem Solving | Strategic Thinking | Collaboration | Storytelling | Change Management ⚙️ Business Analysis Technical Skills: Requirement Analysis | Process Mapping | GAP Assessment | Business User Stories | BRD/SRS Documentation | Agile Practices | RFI/RFP Management | Compliance Impact Analysis | BPM 📘 Business Analysis Core Skills: BABOK V3.0 Practices | Stakeholder Management | Requirement Elicitation | Business Process Optimization | SDLC Support | Regulatory Compliance | Business Research 🏗️ Frameworks & Methodologies: BABOK V3.0 | AIGA Framework | Design Thinking | Agile Ways of Working | SDLC Frameworks 🤖 AI Skills for Business Analysis: Generative AI | Prompt Engineering | AI Agents | AI-Augmented Requirement Engineering | AI-Powered Insight Generation | Intelligent Knowledge Assistants | AI Transformation Practices 🛠️ Tools & Technologies: Microsoft Copilot | ChatGPT | Gemini | Power BI | Mural | Azure DevOps (ADO) | Microsoft Teams | Veeva Portal Value Proposition: Transforming Business Analysis through Artificial Intelligence by combining domain expertise, analytical rigor, and AI-driven innovation to deliver measurable business outcomes and enterprise value.

WORK EXPERIENCE

Business Analyst
01/2026 - Present
Tata Consultancy Services , Mumbai
• Business Analysis & Stakeholder Collaboration
• Partner with business stakeholders, SMEs, product owners, and technical teams to identify business challenges, opportunities, and AI-enabled solutions.
• Facilitate requirement discovery sessions, workshops, and design-thinking activities to capture business needs and operational pain points.
• Serve as the primary bridge between business and development teams, ensuring alignment of expectations, requirements, and project deliverables.
• Drive stakeholder engagement, collaboration, and consensus throughout project execution and delivery.
• AI Solution Enablement
• Leverage Enterprise AI platforms and tools to accelerate business analysis, documentation development, and knowledge management activities.
• Translate business requirements into actionable functional and system requirements to support AI solution design.
• Collaborate with development teams to refine AI use cases, workflows, business rules, and validation scenarios.
• Contribute to AI adoption initiatives while ensuring alignment with business objectives and regulatory expectations.
• Documentation & Compliance Management
• Develop, review, and maintain AI project lifecycle documentation, including:
• o User Requirements Specifications (URS)
• o System Requirements Specifications (SRS)
• o Design Specifications (DS)
• o Process and Operation Manual (POM)
• o General Global Process Ownership Model (GPOM)
• o Technical Installation Plan (TIP) for UAT and Production
• o Quality Plan
• Utilize Enterprise AI capabilities to improve documentation quality, consistency, traceability, and productivity.
• Ensure all project documentation complies with organizational quality standards and compliance requirements.
• GxP & Regulatory Support
• Support AI and digital initiatives across GxP-support and Non-GxP environments.
• Ensure project deliverables meet applicable Life Sciences regulations, quality standards, and validation requirements.
• Participate in validation activities and collaborate with Quality, Compliance, and Business teams to maintain audit readiness.
• Facilitate end-to-end traceability between business requirements, system requirements, testing artifacts, and implementation deliverables.
• Dataset Preparation & AI Model Support
• Collaborate with business teams to create, validate, and maintain Golden Datasets used for AI solution development and testing.
• Work closely with testers to understand requirements and provide structural expertise on datasets.
• Fulfill development team requirements through artifacts, dataset analysis, and reporting based on business-approved data structures.
• Ensure data quality, accuracy, completeness, and business relevance under established governance and stakeholder guidance.
• Design Thinking & Process Improvement
• Apply Design Thinking methodologies to identify, assess, and prioritize business pain points and transformation opportunities.
• Create whiteboard sessions, journey maps, process flows, and visual artifacts to support collaborative problem-solving.
• Drive continuous improvement initiatives by analyzing existing processes and recommending AI-enabled efficiencies.
• Agile Ways of Working & AI Project Lifecycle Participation
• Participate throughout the project lifecycle, from inception through deployment and business adoption.
• Contribute to Agile ceremonies, retrospectives, sprint planning, backlog refinement, testing activities, and release readiness reviews.
• Monitor solution effectiveness and business outcomes to support value realization and business adoption.
Data Analyst and Support Executive
01/2024 - Present
Tata Consultancy Services , Mumbai, Maharashtra, India
• Note: The Process Expert role reflects a transition to new responsibilities while retaining full HR competency recognition, ensuring no downgrade of role. BCC Project (Business Insights)
• Actively contributed to organizational AI initiatives from inception, driving innovation, fostering user adoption, and delivering measurable business value through strategic analysis and stakeholder alignment.
• Completed Core Veeva CRM and Reltio MDM training, ensuring project readiness and enabling the effective use of IS‑compliant LLM models (Copilot, Meta AI) for continuous refresh and optimization.
• Completed intensive internal workshop training in Microsoft Power BI (1,080 minutes of hands‑on labs), supplemented by Advanced Excel and commercial training, thereby strengthening analytical, reporting, and business insight capabilities.
• Submitted a high‑impact AI innovation leveraging WisdomNext low‑code/no‑code frameworks (RAG and multimodal LLM) to drive business transformation.
• Recognized for pioneering contributions and thought leadership with multiple honors—including AI Spark, AI Idea Igniter, and Contextual Master—highlighting excellence in creative problem‑solving and innovation.
Business Process Lead (RMG)
11/2024 - 01/2025
Tata Consultancy Services , Mumbai, Maharashtra, India
• Note: The Process Expert role reflects a transition to new responsibilities while retaining full HR competency recognition, ensuring no downgrade of role. Strategic Transition to Data & Technology‑Driven Business Operations
• Transformed a transitional RMG tenure into a strategic career pivot by ensuring full compliance with organizational processes, proactively navigating internal pathways, and securing a technology focused role (Modern AI) that enabled a successful shift into data analysis and business analysis.
Process Expert (PV Domain Consultant Team) - Drug Safety
08/2015 - 11/2024
Tata Consultancy Services , Mumbai, Maharashtra, India
• Note: The Process Expert role reflects a transition to new responsibilities while retaining full HR competency recognition, in this tenure superseded from Work Process Expert to Process Expert.
• Advanced into the role of Pharmacovigilance (PV) Subject Matter Expert (SME), initiating the journey as a PV Domain Consultant.
• Accountable for PV sales asset development and successfully published deliverables on the organizational digital store from scratch.
• Executed manual regulatory updates and analysis (Regulatory Intelligence – RI), producing detailed impact analysis reports to support compliance and change management from scratch.
• Managed and maintained the pharmacovigilance hub, driving operational efficiency and iteratively enhancing stakeholder engagement from the ground up, while ensuring processes aligned with business needs and compliance standards.
• Developed ICSR SOPs and performed analysis to identify business opportunities, transforming insights into actionable leads that drove organizational growth and informed strategic decisions.
• Contributed as a key team member in authoring a white paper and successfully submitted it to TCS Stylus, showcasing thought leadership and advancing organizational knowledge in pharmacovigilance.
• Engaged and collaborated with stakeholders to procure relevant regulatory and safety information, strengthening decision‑making processes.
Work Process Expert (PV SME Team)
08/2014 - 08/2015
Tata Consultancy Services , Mumbai, Maharashtra, India
• Note: Successful completion of the SME Career Path Program marked my transition from operational responsibilities to a business‑oriented consulting role as Work Process Expert, retaining full HR competency recognition.
• Enrolled in the SME Career Path Program, advancing into the role of Work Process Expert with a focus on business‑oriented responsibilities.
• Delivered key contributions to RFI and RFP processes, supporting business development and client engagement.
• Procured information and data for capability decks, ensuring accuracy and alignment with organizational strengths.
• Prepared capability decks for new active online listening processes and brand watch analysis, showcasing expertise and value propositions to stakeholders.
• Successfully completed the SME Career Path Program, which transitioned me into the PV SME team, moving from an operational role to a business‑oriented consulting role as Work Process Expert.
• Accountable for ICSR process mapping initiatives and conducted GAP analysis to identify areas for improvement and ensure compliance alignment within the team.
• Actively participated in training and development programs, enhancing professional skills and organizational readiness.
Process Executive
05/2012 - 08/2014
Tata Consultancy Services , Mumbai, Maharashtra, India
• This career transition exposed me to stringent markets and drug regulatory environments in Drug Safety offerings across the EU, US, and UK.
• Leveraged broad pharmaceutical industry experience to transition from Regulatory Affairs into Drug Safety, where I managed case operations and strengthened compliance through effective process execution.
Regulatory Affairs Specialist (Project/Consultancy Experience) – Managed end‑to‑end registration process.
01/2012 - 05/2012
AAHELI HEALTHCARE PVT. LTD. , Mumbai Area, India
• Note - The consultancy project, though informal, gave me direct exposure to international regulatory frameworks and positioned me for future consulting roles strengthening compliance expertise and broadening my professional trajectory.
• Independently managed end‑to‑end international product registration, ensuring compliance with global standards and enabling market entry across non‑regulated and semi‑regulated EU and Asian countries.
Executive-QA and Regulatory Affair
06/2010 - 01/2012
IDA FOUNDATION LTD , South Mumbai Area, India
• Note: This role strengthened my regulatory affairs expertise through EU‑specific dossier preparation and global tender management including technology application (JD Edward).
• Prepared and submitted EU‑specific dossiers, including revisions and query responses, ensuring compliance with country‑specific regulatory standards and supporting successful market entry.
Executive – Regulatory Affair
12/2009 - 06/2010
PRIME PHARMACEUTICALS LTD. , Mumbai Area, India
• Note: Reported directly to MD Mr. Ashish under QC mentorship of an RA colleague, leveraging regulatory affairs expertise and collaboration skills to submit dossiers for non‑regulated countries, including ACTD formats.
• Prepared ACTD dossiers and country‑specific submissions for finished formulations, ensuring regulatory compliance.
• Conducted artwork review and verification in line with country‑specific guidelines and standards.
Jr. Executive – Regulatory Affairs
03/2007 - 12/2009
SRS PHARMACEUTICALS PVT. LTD. , Mumbai Area, India
• Note: Elevated from Executive – International Product Registration to Junior Executive – Regulatory Affairs, expanding into FDA liaisoning, ROW dossier preparation, mentoring, and vendor process/method validation under compliance frameworks.
• Assisted in FDA liaison activities and coordinated sample management to support regulatory compliance.
• Prepared country‑specific dossiers for finished formulations across Rest of World (ROW) markets, ensuring timely submissions and approvals.
• Mentored new joiners in FDA liaison processes, providing guidance and knowledge transfer to strengthen team capability.
• Supported process and method validation procurement from vendors, ensuring compliance with regulatory standards and smooth approval workflows.
Management staff (Trainee)
11/2004 - 08/2006
Cipla LTD , Mumbai Area, India
• Note: Post‑graduation, I launched my career at Cipla as Management Staff (Trainee). After probation, I was confirmed as a full‑time employee, entrusted with supporting international market submissions and local FDA regulatory compliance including act as Liaison to FDA.
• Prepared and submitted FDA documentation, ensuring accuracy and adherence to regulatory requirements.

EDUCATION

Doctor of Business Administration (DBA) - (100 % Online - LMS Portal) (IECC and QCID Verified)
11/2025
Atlanta College of Liberal Arts and Sciences (ACLAS) , Atlanta, Georgia, USA GPA: 4.0
PGDM-MM-HB (Specialisation Marketing Management) (Hybrid Mode)
12/2017
Welingkar Institute of Management , South Mumbai Area, India
International MBA (Online - LMS Portal)
12/2014
Ulyanovsk State University , Russian Federation
B.Pharmacy (Full Time - On campus)
04/2004
North Maharashtra University , Jalgaon , Maharshtra state

SKILLS

Technical Skills: Regulatory Affairs & Pharmacovigilance, Generative AI & Prompt Engineering, Agile BA Practices, Business Analysis
Soft Skills: Analytical Thinking & Problem-Solving, Strategic Thinking & Change Agent Mindset, Communication & Collaboration, Critical Thinking & Innovation, Interpersonal Communication, Leadership Development, Continuous upskilling
Tools: Copilot & Microsoft Teams (collaboration & productivity), Argus Drug Safety Database (domain tool for PV ), JD Edwards (QA and Regulatory affairs), Microsoft Visio (Design flowchart), Mural, Confluence, Azure Development Board
Other: Generative AI, Prompt Engineering, Volunteer Engagement with IIBA, Business Research, Publications on BA & Change Management (thought leadership), Community Leadership (Founder of BAiNex, LinkedIn BA network building), Sales Enablement & Market Insights (business-side exposure), Documentation Development Foundation, Change Management & Compliance Alignment, Business Process Analysis & Optimization, Business Acumen, Big-Picture Thinking, Business Opportunity Identification, Change Enablement

CERTIFICATIONS

Metamorph BA
TCS Internal TD
Business Analysis Practitioner Program
TCS Internal TD
Certified Business Research Professional
TCS Internal
Generative AI Professional Certification (GAIPC™)
CertifPro
Prompt Engineering Foundation Professional Certification (CPEFPC™)
CertifPro
Agile Way of Working Foundation
TCS Internal
BDA: Product Specialist Program
TCS Internal
Wings: Business Skills B3 – Complex Problem Solving
TCS Internal

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