Sr. Manager – Regulatory Labeling (End-to-End) Job | Sun Pharma

📍 Location: Gurgaon / Mumbai
🏢 Company: Sun Pharmaceutical Industries Ltd
💼 Role: Sr. Manager – Regulatory Labeling (End-to-End)
🏬 Business Unit: Clinical Development
🎯 Job Grade: G9A / G9B
📅 Posted On: 10 Feb 2026

Job Overview

Sun Pharma is seeking a Senior Manager – Regulatory Labeling to provide strategic leadership and end-to-end oversight of the global labeling lifecycle across development and marketed products. The role ensures regulatory compliance, global consistency, and timely patient and physician communication across US, EU, and ROW markets.

Purpose of the Role

Lead the global labeling lifecycle from safety signal detection and CCDS/CCSI ownership through USPI/EU SmPC development, health authority negotiations, affiliate implementation, and artwork/packaging execution, ensuring compliance with global regulations and ICH guidelines.

Key Responsibilities

Global Labeling Strategy & Governance

• Own global labeling strategy for development and marketed products
• Chair / lead Global Labeling Committee (GLC/GLOC) for cross-functional decision-making
• Establish and continuously improve end-to-end labeling processes, SOPs, and change control
• Apply Quality Risk Management aligned with ICH Q8/Q9/Q10
• Ensure governance and traceability for label changes driven by:
  • Safety signals
  • Clinical updates
  • CMC changes
  • Regulatory intelligence

CCDS / Core Labeling Ownership

• Author, maintain, and approve CCDS / CCSI as the single source of truth
• Manage strengthening/weakening deviations with documented rationale
• Align Reference Safety Information (RSI) for pharmacovigilance reporting
• Conduct competitive precedent reviews and harmonize core labeling content

Regional Labeling & Health Authority Interactions

• Lead development and updates of:
  • USPI (FDA format)
  • EU SmPC / PL (EMA QRD templates)
• Manage health authority negotiations and responses (FDA, EMA)
• Oversee annotated labels, HA queries, and variation procedures across:
  • Centralized
  • Decentralized
  • National routes
• Handle local exceptions and blue-box requirements

Country Implementation & Artwork / Packaging

• Drive affiliate implementation aligned with CCDS
• Oversee:
  • Local PI adaptations
  • Translations & linguistic reviews
  • Readability and user testing
  • Artwork control (cartons, blisters, labels)
• Manage supply chain change control for labeling updates

Cross-Functional Leadership

• Chair Labeling Working Group (LWG) with:
  • Regulatory
  • Safety / PV
  • Clinical
  • Medical Affairs
  • CMC
  • Commercial & Supply Chain
• Ensure data provenance from source documents (CSR, PV signals, CMC) to label text
• Train and mentor labeling teams; build capability frameworks and knowledge management

Inspection Readiness & Compliance

• Ensure audit-ready labeling documentation and change histories
• Maintain source-to-sentence traceability
• Proactively address inspection risks (e.g., delayed safety variations, RSI updates)

Qualifications & Experience

• Education: M.Pharm / Advanced degree in Life Sciences or Pharmacy
• Experience: 12–18 years (10–15+ years global regulatory labeling experience)
• Proven leadership on high-complexity products and HA negotiations (USPI / SmPC)
• Deep expertise in:
  • FDA & EMA labeling regulations
  • EMA QRD templates
  • ICH Q8 / Q9 / Q10
  • CIOMS & core labeling principles

Key Skills & Competencies

• Strategic thinking & regulatory risk management
• High-quality scientific label authoring with strong annotation discipline
• Strong stakeholder influence and executive-level communication
• Process and digital fluency across:
  • RIM systems
  • EDMS
  • Labeling trackers
  • Structured Content Authoring (SCA)
  • Artwork & packaging management platforms

About Sun Pharmaceutical Industries Ltd

Sun Pharma is a leading global pharmaceutical company committed to innovation, quality, and patient-centric healthcare solutions. At Sun Pharma, employees are encouraged to take charge, thrive together, and grow every day in a supportive and collaborative environment.

How to Apply

https://careers.sunpharma.com/job/Gurgaon-Sr_-Manager-Regulatory-Labeling-%28End-to-End%29/49002944/

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