**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, youll 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 others 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 executionensuring compliance, global consistency, and timely patient/physician communications **Key Responsibilities** **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 crossfunctional alignment and decisions + Establish and continuously improve **endtoend (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/bluebox** requirements. + Oversee submissionready 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) CrossFunctional 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 ( **sourcetosentence annotations** ) are auditready; address common inspection pitfalls (e.g., failure/delay in safety variations or RSI updates). **Qualifications & Experience** + Advanced degree in **Life Sciences/Pharmacy** ; 1015+ years in Regulatory Labeling with **global** scope; track record leading highcomplexity 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** (executivelevel briefings; crossfunctional 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. Lets 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)._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.