Manager Regulatory - Artworks & Labelling (End-to-End) (India)

Manager Regulatory - Artworks & Labelling (End-to-End) (India)

01 Aug
|
Sun Pharmaceuticals
|
India

01 Aug

Sun Pharmaceuticals

India

**Job Title:** Manager Regulatory - Artworks & Labelling (End-to-End) **Business Unit:** GDO **Job Grade** G11A **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. **Job Summary** To manage, coordinate, and deliver US market pharmaceutical artwork while also providing artwork lifecycle and execution support to assigned regional/global markets, ensuring compliance with regulatory requirements, company standards, and timelines from concept to approval and implementation for Sun Pharmas US innovator portfolio. **Area Of Responsibility** + Manage endtoend US pharmaceutical artwork (cartons, labels, leaflets, inserts) from initiation to final approval, ensuring compliance with US FDA labeling requirements. + Provide artwork execution and lifecycle support for assigned regional/global markets, including adaptations, translations, and countryspecific requirements. + Coordinate and implement artwork changes arising from regulatory updates, safety changes, variations, and lifecycle management activities. + Drive artwork workflows using Agile PLM, including creation, routing, version control, approvals,



archival, and audit readiness. + Liaise with Regulatory Affairs, Quality, Packaging Development, Supply Chain, Marketing, and external artwork vendors to ensure accurate and timely delivery. + Ensure adherence to GxP, internal SOPs, change management, and data integrity standards while minimizing labeling and artwork risks. + Support product launches, submissions, and postapproval activities by delivering rightfirsttime artwork within committed timelines. + Contribute to process improvements, standardization, and best practices, and support training or mentoring of junior team members as required. **Qualification, Skill and Competencies Requirements** + Bachelors degree in Pharmacy, Life Sciences, or related field (Masters preferred). + 47+ years of experience in Pharmaceutical artwork, labeling, or regulatory operations, US market artwork handling (mandatory), experience supporting multiple global/regional markets is preferred + Experience with artwork change control, versioning, and approvals. + Indepth knowledge of US FDA labeling regulations and guidance + Strong handson experience with Agile PLM or similar artwork management systems.



+ Strong communication and stakeholder management skills. **Travel Estimate** **Job Requirements** **Educational Qualification** Masters degree preferred. **Experience** _Tenure_ : 4 to 8 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 skilled 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.

📌 Manager Regulatory - Artworks & Labelling (End-to-End) (India)
🏢 Sun Pharmaceuticals
📍 India

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