Job Description: Global Labeling Manager
Job ID
REQ-10078186
Date Posted
22 May 2026
Location
India (Site: Hyderabad – Office)
Company
Novartis Healthcare Private Limited (IN10)
Division / Business Unit
Development / Development
Functional Area
Research & Development
Job Type
Full-time (Regular)
Shift
No
Role Summary
The Global Labeling Manager provides labeling and artwork strategy, regulatory intelligence, and product knowledge required to develop, market, and maintain pharmaceutical products.
The role ensures accurate, consistent, and compliant global labeling content across products and markets, supporting high-quality and traceable labeling systems.
Key Responsibilities
1. Global Labeling Strategy & Document Ownership
Serve as labeling lead for assigned products
Develop and maintain compliant global labeling documents, including:
Core Data Sheet (CDS)
Base Product Labeling (BPL)
Base Safety Sheet (BSS)
Instructions for Use (IFU)
Manage major market labels such as:
US Prescribing Information (USPI/PPI/MG)
EU SmPC / PIL
Other priority country labeling formats
2. Cross-Functional Coordination
Organize and lead ELTF (Expert Labeling Task Force) meetings
Align stakeholders on labeling content and review comments
Collaborate with Global Labeling Directors / Associate Directors
Support multiple projects as assigned across labeling functions
3. Regulatory & Competitive Intelligence
Conduct research on:
Competitor labeling
Global regulatory requirements
Clinical study and safety data
Translate insights into compliant labeling content
4. Regulatory Documentation & Submissions
Prepare documentation supporting CDS updates
Contribute to responses to Health Authority queries
Ensure compliance with global labeling standards and regulations
5. Implementation & Compliance
Ensure timely implementation of labeling changes across countries
Maintain alignment with CDS requirements
Support inspection and audit readiness activities
6. Quality & Documentation Management
Maintain accurate document control:
Version management
Reference tracking
Rationale documentation
Ensure traceability and governance compliance for all labeling content
7. Training & Continuous Improvement
Mentor new team members
Support continuous improvement initiatives in labeling processes
8. Internal Product Labeling (IPLs)
Develop and maintain Internal Product Labeling documents
Minimum Requirements
Education
Science-based Bachelor’s (BS) or Master’s (MS) degree
Advanced degree preferred
Experience
2–5 years of experience in:
Global Labeling
Regulatory Affairs
Pharmaceutical development functions
Proven experience in labeling drafting and maintenance
Technical Knowledge
Understanding of labeling frameworks:
Core Data Sheet (CDS)
US Prescribing Information (USPI)
EU SmPC and PIL formats
Ability to interpret clinical and safety data into labeling language
Familiarity with internal regulatory standards and processes
Core Skills
Strong attention to detail and documentation discipline
Experience with version control and traceability systems
Ability to facilitate cross-functional meetings (e.g., ELTF)
Strong communication and collaboration skills
Ability to prioritize and manage multiple tasks
Proactive issue identification and escalation
Continuous improvement mindset
Exposure to audit and inspection readiness activities
About Novartis
Novartis is a global healthcare company committed to improving and extending people’s lives. The organization focuses on innovative science, collaboration, and patient-centered solutions to address serious diseases.
Working at Novartis means joining a community of professionals dedicated to delivering breakthroughs that transform patient outcomes.
Benefits & Culture
Focus on professional and personal growth
Collaborative and innovation-driven environment
Strong emphasis on patient impact and scientific excellence
Access to structured learning and development opportunities
Application Information
Part of the Development organization
Full-time, permanent role
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