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Expert Regulatory Labeling Operations

7-10 years
Not Disclosed
10 Nov. 27, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Expert Regulatory Labeling Operations

Job ID: 293667 | Location: Bangalore, Karnataka, India | Full-Time

About the Role

The Expert Regulatory Labeling Operations position is a key strategic role responsible for ensuring global labeling compliance, operational excellence, and cross-functional regulatory alignment. This role supports critical labeling processes, safety variation compliance, automation initiatives, and regulatory documentation for a global pharmaceutical environment. The position requires strong expertise in labeling strategy, regulatory operations, and end-to-end labeling lifecycle management.

This opportunity is ideal for professionals who excel in highly regulated environments and can lead complex labeling compliance processes that support patient safety, product quality, and corporate regulatory objectives.


Key Responsibilities

Labeling Compliance & Operations

  • Monitor safety variation compliance and present performance metrics to Global Regulatory Affairs (GRA) Governance bodies.

  • Deliver quarterly Safety Variation KPIs to the GPS Compliance Review Board chaired by the EU QPPV.

  • Conduct quality checks, finalize, and deliver PSMF Annex F2.3 (A, B, C sub-annexes).

  • Provide strategic inputs for Labeling Process Automation initiatives.

  • Support global Pharmacovigilance (PV) and labeling audits/inspections.

  • Lead continuous process improvements, including Veeva Breeze optimization.

  • Create, update, and maintain Labeling Quality Documents.

  • Oversee labeling content deviation management and artwork initiation compliance processes.

Labeling Strategy Support (as required)

  • Serve as Labeling Product Lead for marketed products.

  • Develop, update, and manage Core Labeling Documents.

  • Coordinate cross-functional labeling discussions on key regulatory topics.

  • Provide labeling data for Health Authority queries and PBRER submissions.

  • Ensure up-to-date maintenance of MRP, DCP, and CP product information.


Cross-Functional Collaboration

Internal Teams

  • Global Regulatory Affairs

  • Global Healthcare Operations

  • Global Regulatory Operations

  • Global Patient Safety and EU QPPV Office

  • IT and digital systems teams

External Partners

  • Veeva and other IT solution vendors

  • Label Net forums and compliance workgroups


Required Qualifications & Experience

  • Education: MSc in Pharmaceutical Sciences or related discipline.

  • Experience: 7–10 years of experience in Regulatory Labeling Strategy, Operations, and Global Labeling Compliance in the pharmaceutical industry.

  • Strong knowledge of global labeling regulations, compliance processes, and operational labeling workflows.

  • Proven expertise with Veeva Vault, Veeva Breeze, and regulatory IT systems.

  • Excellent attention to detail, time management, project management, and communication skills.

  • Demonstrated ability to work cross-functionally in a fast-paced, compliance-driven environment.


Why Join Us?

We are a global organization committed to scientific innovation, diversity, inclusion, and professional growth. Our teams collaborate across Healthcare, Life Science, and Electronics to deliver impactful solutions for patients and communities worldwide.

We offer an inclusive workplace where your expertise contributes to advancing regulatory excellence and strengthening global compliance standards.


Apply Now

Be part of a team that is dedicated to driving regulatory innovation and ensuring the highest standards of global labeling compliance.