Sun Pharma Require Regulatory Labeling Sr. Manager

Sun Pharma is India’s No. 1 pharmaceutical company and a leading global player in specialty medicines. With over 40 manufacturing facilities and a diverse portfolio, we deliver high-quality medicines across 100 countries. Driven by a commitment to innovation, we continuously strive to enhance access to medicines and improve patient care, creating better health outcomes for millions around the world.

Post : Sr. Manager - Regulatory Labeling (End-to-End)

Job Description
1) Global Labeling Strategy & Governance
• Own the global labeling strategy across development and marketed products; chair/lead the Global Labeling Committee/Global Labeling Oversight Committee (GLC/GLOC) to drive cross functional alignment and decisions
• Establish and continuously improve end to end (E2E) labeling processes, standards, SOPs, and change control, incorporating quality risk management principles aligned with ICH Q8/Q9/Q10.
• Maintain robust governance for label changes triggered by safety signals, clinical/CMC updates, and regulatory intelligence; ensure harmonized global implementation timelines and traceability.
2) CCDS / Core Labeling Ownership
• Author, maintain, and approve the CCDS/CCSI as the single source of truth, managing strengthening/weakening deviations and documenting rationale; align Reference Safety Information (RSI) for PV reporting.
• Lead competitive precedent reviews and core content harmonization across therapeutic areas.
3) Regional Labels (US/EU/ROW) & Health Authority Interactions
• Lead creation/updates of USPI (aligned to FDA format) and EU SmPC/PL (aligned to EMA QRD templates), including negotiation with health authorities and management of local exceptions/blue box requirements.
• Oversee submission ready annotated labels, responses to FDA/EMA queries, and variation procedures across centralized, decentralized, and national routes.

4) Country Implementation & Artwork/Packaging
• Drive downstream implementation: affiliate alignment to CCDS, local PI adaptation, translations/linguistic review, readability/user testing, artwork control (cartons, blisters, labels), and supply chain change management.
5) Cross Functional Leadership
• Chair the Labeling Working Group (LWG) with Regulatory, Safety/PV, Clinical, Medical Affairs, CMC, Commercial, and Supply Chain; ensure data provenance from source (CSR, PV signal eval, CMC documents) to label text
• Provide training/mentorship to labeling staff; develop capability frameworks and knowledge management practices aligned with ICH Q8/Q9/Q10.
6) Inspection Readiness & Compliance
• Ensure labeling files, history of changes, and traceability (source to sentence annotations) are audit ready; address common inspection pitfalls (e.g., failure/delay in safety variations or RSI updates).

Candidate Profile
• Advanced degree in Life Sciences/Pharmacy; 10–15+ years in Regulatory Labeling with global scope; track record leading high complexity products and negotiations (USPI/SmPC).
• Deep expertise in FDA/EMA labeling regulations, ICH Q8/Q9/Q10, CIOMS/core labeling principles, and EMA QRD requirements.
• Proven leadership of GLC/GLOC/LWG, managing local exceptions, affiliate alignment, and continuous improvement.

Skills & Competencies
• Strategic thinking & risk management (anticipate HA perspectives; craft fallback positions
• Label authoring excellence (clear, scientifically defensible text; annotated to source).
• Process & digital fluency (RIM/IDMP metadata, SCA/component management, artwork workflows).
• Stakeholder influence & communication (executive level briefings; cross functional alignment).
• RIM systems (for submissions/variations), EDMS (lifecycle files/annotations), Labeling trackers, component libraries for SCA, and artwork management platforms.

Additional Information
Experience : 12 to 18 years
Qualification : M.Pharm
Location : Gurgaon / Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Development
End Date : 31st May 2026