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Senior Manager – Regulatory Labeling (End-To-End)

Sun Pharma
Sun Pharma
10-15 years
preferred by company
Gurgaon, Mumbai, India
1 May 14, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing

Senior Manager – Regulatory Labeling (End-to-End)

Location: Gurgaon, Haryana, India / Mumbai, Maharashtra, India
Employment Type: Full-Time
Department: Clinical Development / Global Regulatory Affairs / Regulatory Labeling
Experience Required: 10–15+ Years


Job Overview

A strategic senior leadership opportunity is available for an experienced Senior Manager – Regulatory Labeling (End-to-End) within the global pharmaceutical regulatory affairs domain. This role is ideal for professionals with deep expertise in global regulatory labeling, CCDS/CCSI management, USPI development, EU SmPC compliance, labeling governance, health authority negotiations, artwork implementation, and pharmacovigilance labeling strategy.

The selected candidate will lead the end-to-end global labeling lifecycle across development and marketed pharmaceutical products, ensuring regulatory compliance, labeling consistency, timely implementation, and effective patient and healthcare professional communication across global markets.

This role is highly suited for professionals seeking advancement in global regulatory affairs leadership, labeling strategy, product lifecycle compliance, pharmacovigilance regulatory operations, and international pharmaceutical governance.


Key Responsibilities

Global Labeling Strategy & Governance

  • Own and drive global regulatory labeling strategy across development-stage and marketed pharmaceutical products
  • Lead enterprise-wide end-to-end labeling governance frameworks
  • Chair and manage:
    • Global Labeling Committee (GLC)
    • Global Labeling Oversight Committee (GLOC)
    • Labeling Working Group (LWG)
  • Establish, optimize, and govern labeling SOPs, workflows, standards, and controlled processes
  • Implement quality risk management principles aligned with:
    • ICH Q8
    • ICH Q9
    • ICH Q10

Core Labeling Ownership (CCDS / CCSI / RSI)

  • Author, maintain, and govern:
    • Company Core Data Sheet (CCDS)
    • Company Core Safety Information (CCSI)
    • Reference Safety Information (RSI)
  • Maintain CCDS as the global source of truth for product labeling
  • Manage strengthening and weakening deviations with documented regulatory rationale
  • Drive harmonization of core safety and product information across therapeutic portfolios
  • Conduct competitive label benchmarking and precedent analysis

Regional Labeling Management (US / EU / ROW)
Lead regulatory labeling development and lifecycle management for:

  • US Prescribing Information (USPI)
  • EU Summary of Product Characteristics (SmPC)
  • Patient Leaflets (PL)
  • Rest of World (ROW) product labels

Responsibilities include:

  • FDA-aligned labeling development
  • EMA QRD template compliance
  • Label variation management
  • Regional regulatory alignment
  • Local exception management
  • Blue-box requirement oversight

Health Authority Interaction & Regulatory Negotiations

  • Lead strategic regulatory labeling negotiations with:
    • US FDA
    • EMA
    • Regional health authorities
    • Country regulators
  • Manage:
    • Submission-ready annotated labels
    • Agency response documentation
    • Label query resolution
    • Label approval negotiation strategy
  • Support centralized, decentralized, and national regulatory pathways

Country Implementation & Artwork Governance
Drive downstream implementation activities including:

  • Affiliate alignment to CCDS
  • Local product information adaptation
  • Translation and linguistic review
  • Readability testing
  • User testing
  • Packaging label implementation
  • Carton, blister, and artwork control
  • Supply chain labeling change coordination

Ensure compliant and timely execution across international markets.

Cross-Functional Leadership
Collaborate with:

  • Regulatory Affairs
  • Pharmacovigilance / Drug Safety
  • Clinical Development
  • Medical Affairs
  • CMC / Manufacturing
  • Commercial teams
  • Supply Chain
  • Regional affiliates
  • Quality teams

Ensure traceability of labeling content from:

  • Clinical Study Reports (CSRs)
  • Safety signal evaluations
  • CMC source documents
  • Regulatory decisions
  • Medical evidence

Inspection Readiness & Compliance

  • Maintain audit-ready labeling documentation and historical traceability
  • Ensure source-to-sentence annotation integrity
  • Support regulatory inspections and compliance reviews
  • Address labeling-related inspection risks, including:
    • Delayed safety variations
    • RSI misalignment
    • Label governance gaps
    • Traceability deficiencies

Team Leadership & Capability Building

  • Mentor and develop labeling professionals
  • Build organizational regulatory labeling capability frameworks
  • Support training, process excellence, and knowledge management
  • Drive continuous improvement initiatives across global labeling operations

Required Qualifications

Educational Qualifications
Candidates must hold:

  • Advanced Degree in:
    • Life Sciences
    • Pharmacy
    • Regulatory Sciences
    • Pharmaceutical Sciences
    • Related healthcare/scientific disciplines