Sr Manager -Regulatory Labeling End-to-End

Job Title

Sr.Manager 2/1 – Regulatory Labelling

Business Unit

Clinical Development

Job Grade

G9A/B

Location :

Gurgaon/Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Purpose of the Role

Provide strategic leadership and operational oversight for the global labeling lifecycle—from signal detection and Company Core Data Sheet (CCDS/CCSI) authoring to USPI/EU SmPC development, health authority negotiations, affiliate implementation, and artwork/packaging execution—ensuring compliance, global consistency, and timely patient/physician communications

Key Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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).
  
  

Qualifications & Experience

• 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.
  
  

Bottom of Form

Travel Estimate

Job Requirements

Educational Qualification

M.Pharm

Experience

Tenure : 12 to 18 years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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