Job Title: Senior Manager – Regulatory Labeling (End-to-End)
Location: Gurgaon / Mumbai, India
Business Unit: Clinical Development
Company: Sun Pharmaceutical Industries Ltd
Employment Type: Full-Time
Experience Required: 12–18 Years
Education Required: M.Pharm
Senior Manager – Regulatory Labeling (Global End-to-End Leadership)
Sun Pharmaceutical Industries Ltd is hiring an experienced Senior Manager – Regulatory Labeling to lead global end-to-end (E2E) labeling strategy across development and marketed products. This strategic leadership role is responsible for regulatory compliance, global label harmonization, and health authority engagement across the US, EU, and Rest of World (ROW) markets.
This opportunity is ideal for senior regulatory professionals with strong expertise in global labeling lifecycle management, CCDS governance, FDA/EMA negotiations, and structured content authoring environments.
Role Overview
The Senior Manager – Regulatory Labeling will provide strategic oversight for the complete labeling lifecycle — from signal detection and CCDS/CCSI development to US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), affiliate implementation, and packaging/artwork governance.
The role ensures alignment with ICH Q8, Q9, and Q10 quality frameworks while maintaining global regulatory compliance and inspection readiness.
Key Responsibilities
Global Labeling Strategy & Governance
Own and drive global labeling strategy for development and commercial products.
Lead Global Labeling Committee (GLC/GLOC) to enable cross-functional decisions.
Strengthen end-to-end labeling processes, SOPs, governance standards, and change control systems.
Apply risk-based quality management principles aligned with ICH guidelines.
Ensure traceability and timely global implementation of labeling updates triggered by safety signals, CMC changes, or regulatory intelligence.
CCDS / Core Labeling Ownership
Author, maintain, and approve CCDS/CCSI as the global source document.
Manage strengthening/weakening deviations with documented scientific rationale.
Align Reference Safety Information (RSI) with Pharmacovigilance reporting requirements.
Conduct competitive labeling reviews and therapeutic area harmonization.
Regional Labeling & Health Authority Interaction
Lead lifecycle management of:
USPI aligned with FDA labeling format.
EU SmPC and Package Leaflet aligned with EMA QRD templates.
Manage health authority negotiations and regulatory queries.
Oversee annotated labeling submissions and variation procedures across centralized, decentralized, and national routes.
Handle local exceptions and blue-box requirements where applicable.
Affiliate Implementation & Artwork Governance
Drive global-to-local alignment of labeling updates.
Oversee translations, linguistic review, readability testing, and local PI adaptation.
Manage artwork updates including cartons, blisters, and packaging labels.
Coordinate supply chain change management for smooth rollout.
Cross-Functional Leadership
Chair Labeling Working Group (LWG) with Regulatory, Safety, Clinical, Medical Affairs, CMC, Commercial, and Supply Chain teams.
Ensure source-to-label traceability from CSR, PV signal evaluations, and CMC documentation.
Mentor labeling professionals and implement structured knowledge management systems.
Inspection Readiness & Compliance
Maintain audit-ready labeling lifecycle documentation.
Ensure source-to-sentence annotation and regulatory traceability.
Proactively mitigate inspection risks including delays in safety variations and RSI updates.
Required Qualifications
M.Pharm (Master of Pharmacy) or equivalent advanced Life Sciences qualification.
12–18 years of global Regulatory Labeling experience.
Proven track record in managing complex labeling portfolios and global submissions.
Demonstrated experience in FDA and EMA labeling negotiations.
Experience leading Global Labeling Committees and cross-functional governance teams.
Technical Expertise
Strong knowledge of FDA and EMA labeling regulations.
In-depth understanding of ICH Q8, Q9, Q10 frameworks.
Experience with CIOMS core labeling principles.
Expertise in EMA QRD templates and global variation procedures.
Proficiency in:
Regulatory Information Management (RIM) systems
Electronic Document Management Systems (EDMS)
Structured Content Authoring (SCA) platforms
Artwork and labeling change management systems
IDMP metadata frameworks
Core Competencies
Strategic regulatory leadership and risk management.
High-level scientific writing and defensible label authoring skills.
Strong executive communication and stakeholder alignment capability.
Digital fluency in labeling lifecycle and structured content environments.
Cross-functional global collaboration skills.
Travel Requirement
Limited travel based on project and regulatory needs.
About Sun Pharmaceutical Industries Ltd
Sun Pharma is one of the world’s leading specialty generic pharmaceutical companies with a strong global presence across regulated and emerging markets. This role offers the opportunity to shape global labeling strategy, engage with international regulatory authorities, and contribute to regulatory excellence within a high-impact clinical development environment.
Disclaimer
This job description outlines the general scope and level of responsibilities associated with the role. It is not an exhaustive list of duties and may evolve in alignment with business requirements.
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