Expert – Regulatory Labeling Operations
Job ID: 293667
Location: Bangalore, Karnataka, India
Employment Type: Full-time
About the Organization
We are a global science and technology organization delivering innovative solutions across Healthcare, Life Science, and Electronics. With a strong international presence, our teams collaborate across regions to advance patient safety, regulatory compliance, and sustainable innovation. We foster a culture of curiosity, accountability, and inclusion, empowering professionals to contribute meaningfully to global healthcare outcomes.
Role Overview
The Expert – Regulatory Labeling Operations will be responsible for ensuring global labeling compliance across marketed products, with a strong focus on safety variation monitoring, operational excellence, and process optimization. This role interfaces extensively with Global Regulatory Affairs, Global Patient Safety, IT teams, and external vendors to maintain high-quality, compliant labeling activities throughout the product lifecycle.
Key Responsibilities
Labeling Compliance and Operations
Monitor global safety variation compliance and present compliance outcomes to Global Regulatory Affairs governance teams.
Prepare and present quarterly safety variation KPIs to the Global Patient Safety Compliance Review Board, chaired by the EU QPPV.
Perform quality control, finalization, and timely delivery of PSMF Annex F2.3 (sub-annexes A, B, and C) to Global Patient Safety.
Provide subject matter input for labeling process automation initiatives and digital transformation projects.
Support pharmacovigilance and labeling audits and regulatory inspections globally.
Drive continuous process improvement initiatives, including optimization of Veeva Breeze and related labeling workflows.
Develop, review, and maintain labeling quality documents, SOPs, and guidance materials.
Oversee labeling content deviation management and artwork initiation compliance checks.
Labeling Strategy Support (as workload permits)
Act as Labeling Product Lead for assigned marketed product portfolios.
Create, update, and oversee the implementation of Core Company Data Sheets (CCDS) and other core labeling documents.
Coordinate labeling team discussions on key regulatory and safety labeling topics.
Provide labeling inputs for Health Authority queries and Periodic Benefit-Risk Evaluation Reports (PBRERs).
Manage updates and maintenance of product information for MRP, DCP, and Centralized Procedure (CP) products.
Cross-Functional Collaboration
Internal Interfaces
Global Regulatory Affairs
Global Regulatory Operations
Global Healthcare Operations
Global Patient Safety and EU QPPV Office
IT and Digital Solutions Teams
External Interfaces
Veeva and other regulatory IT solution providers
Labeling and regulatory industry forums, including Label Net
Required Qualifications and Experience
Education
Master of Science (MSc) in Pharmaceutical Sciences or a related discipline.
Experience
7 to 10 years of professional experience in Regulatory Labeling Strategy and Labeling Operations within the pharmaceutical industry.
Extensive hands-on experience with Veeva systems and regulatory IT tools commonly used in global regulatory affairs.
Strong understanding of global labeling compliance requirements and operational processes across major regulatory regions.
Skills and Competencies
Exceptional attention to detail and strong quality-focused mindset.
Proven project management, time management, and organizational skills.
Excellent written and verbal communication, presentation, and stakeholder management abilities.
Ability to work effectively in complex, matrixed, and global environments.
Proactive, collaborative, and results-driven professional approach.
What We Offer
A globally inclusive and diverse workplace culture.
Opportunities for leadership, professional growth, and global exposure.
Engagement in high-impact regulatory and patient safety initiatives.
A supportive environment that values expertise, innovation, and continuous improvement.
Apply Now
Join a global regulatory organization where your expertise in labeling operations directly supports patient safety, regulatory compliance, and healthcare excellence worldwide.
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