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Project Analyst - Regulatory Business Transformation

Merck KGaA
5+ years
INR 12 LPA – 16 LPA
Bangalore, India
1 June 19, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: ICH guidelines, ICSR Case Processing, Labelling Assessment, MedDRA Coding, mRS and EQ-5D-5L, Triage of ICSRs, WHO DD Coding

Project Analyst – Regulatory Business Transformation

Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Work Mode: On-Site

Role Summary

The Project Analyst – Regulatory Business Transformation plays a critical role at the intersection of Regulatory Affairs and Project Management, supporting the successful launch of Life Science products while driving operational excellence across regulatory business processes.

This position combines regulatory expertise with project delivery capabilities to ensure timely product launches, effective stakeholder coordination, performance monitoring, and continuous process improvement. The role requires strong analytical skills, cross-functional collaboration, and the ability to translate complex regulatory and operational data into actionable business insights.

Key Responsibilities

Regulatory Affairs Management

  • Collaborate with:

    • Global Product Management Teams

    • Regulatory Affairs Functions

    • External Stakeholders

  • Support accurate and timely execution of product launches across the Life Science portfolio.

  • Gather, consolidate, and validate:

    • Product Composition Data

    • Physical Property Information

    • Regulatory Documentation

    • Hazardous Substance Information

  • Perform assessments and support hazardous material characterization activities.

  • Ensure regulatory decisions are accurately implemented throughout the product lifecycle.

  • Partner with internal processing teams to maintain regulatory compliance and data integrity.

  • Support regulatory documentation and compliance initiatives across global markets.

Project Management & Delivery

  • Own end-to-end execution of assigned regulatory and transformation projects.

  • Ensure projects are delivered within:

    • Scope

    • Timelines

    • Milestones

    • Stakeholder Expectations

  • Develop and maintain project plans and tracking mechanisms.

  • Coordinate activities across multiple business functions and stakeholders.

  • Apply project management methodologies to ensure successful project outcomes.

  • Monitor project risks and develop mitigation strategies to ensure uninterrupted progress.

Performance Monitoring & KPI Management

  • Track and monitor operational and project-related Key Performance Indicators (KPIs).

  • Analyze performance metrics to identify trends, bottlenecks, and improvement opportunities.

  • Proactively identify risks and escalation points.

  • Develop performance improvement plans with defined actions, owners, and timelines.

  • Support operational excellence initiatives through data-driven decision-making.

Stakeholder Management & Communication

  • Build and maintain strong working relationships with:

    • Regulatory Teams

    • Product Management

    • Supply Chain Functions

    • Global Business Stakeholders

    • External Partners

  • Facilitate effective communication across cross-functional teams.

  • Influence stakeholders and drive alignment without direct authority.

  • Ensure transparency through regular project and performance updates.

Reporting & Business Insights

  • Prepare:

    • Project Status Reports

    • KPI Dashboards

    • Executive Summaries

    • Leadership Presentations

  • Translate complex operational and regulatory data into actionable insights.

  • Provide recommendations to leadership based on performance trends and project outcomes.

  • Support strategic decision-making through clear and effective reporting.

Process Improvement & Business Transformation

  • Identify opportunities to improve regulatory and operational processes.

  • Drive continuous improvement initiatives across regulatory workflows.

  • Support transformation projects focused on efficiency, compliance, and scalability.

  • Promote best practices in project management and operational excellence.

  • Contribute to organizational change management and business transformation efforts.

Required Qualifications

Education

  • Master's Degree in:

    • Natural Sciences

    • Life Sciences

    • Chemistry

    • Biotechnology

    • Pharmaceutical Sciences

    • Related Scientific Discipline

Experience

  • Minimum 5+ years of experience in:

    • Regulatory Affairs

    • Project Management

    • Business Transformation

    • Operational Excellence Programs

  • Experience supporting product launches and regulatory compliance initiatives.

  • Proven experience managing cross-functional projects in global environments.

  • Experience in KPI monitoring, operational performance analysis, and process improvement initiatives.