p Who We Are p Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of US$6 billion.
Supported by more than 40 manufacturing facilities and more than ****** employees around the globe, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.
/pp Over the last two decades, Sun Pharma has established itself as a leading player in the generics market, and are rapidly ramping up their presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.
/pp Values /pp At Sun Pharma our core values—Humility, Integrity, Passion, and Innovation—are part of our unique culture, known as Sunology.
/pp We are empowering our employees to create their "Own Sunshine".
We believe in being Better Everyday by investing on lifelong learning, Taking Charge by owning our impact, and Thriving Together in a workplace where collaboration is encouraged.
We are committed to being an inclusive and equitable employer, valuing diverse perspectives and creating an environment where all individuals feel respected, heard, and inspired to bring their best selves to work.
/pp Role Overview /pp We are seeking a motivated Regulatory Affairs Artwork Specialist with 1–2 years of experience in a multinational pharmaceutical environment.
The ideal candidate will have hands-on expertise in packaging materials creation and lifecycle management, supporting regulatory activities for medicinal products in Italy.
/pp Key Responsibilities /pp The selected candidate will be responsible for managing regulatory and artwork activities associated with new Marketing Authorizations (MAs) and lifecycle management of products registered via MRP, DCP,



and CP procedures.
/pp Key tasks include: /pulli Supporting dossier preparation and submission activities /lili Managing Product Operating Licenses (POL) assignment /lili Coordinating artwork creation, review, and approval (carton boxes, labeling, and PILs) /lili Maintaining and updating national regulatory databases /lili Submitting applications via AIFA Front End / CESP platforms /lili Handling End of Procedure (EoP) communications with AIFA /lili Managing national implementation of variations under the "Silenzio/Assenso" procedure /lili Overseeing publication of regulatory updates in the Italian Official Gazette /lili Managing Farmastampati processes /lili Ensuring accurate maintenance of the XEVMPD database /li /ulp Education /pulli Degree in Life Sciences or a related field (preferred) /li /ulp Professional Experience /pulli1–2 years of experience in a Regulatory Affairs department within the pharmaceutical industry /lili Practical experience in artwork preparation and review for packaging materials (cartons, labels, PILs) /li /ulp Language Skills /pulli Native or fluent Italian /lili Good command of English /li /ulp Technical Skills /pulli Strong knowledge of QRD templates and Blue Box requirements /lili Proficiency in Microsoft Office (Excel, Word, PowerPoint) and PDF tools /lili Familiarity with AIFA Front End and submission systems /lili Experience with virtual collaboration tools (e.g. Microsoft Teams, GoToMeeting) /li /ulp Core Competencies /pulli Strong attention to detail and accuracy /lili Excellent organizational and planning skills /lili Effective communication and interpersonal abilities /lili Results-oriented with a proactive mindset /lili High level of integrity and strong work ethic /li /ulp Location /pp Milan, Italy (Italian Affiliate of Sun Pharma) /pp Hybrid working model: 2 days in the office /p /p

📌 Regulatory Affairs Artwork Specialist (Bardi)
🏢 SUN PHARMA
📍 Bardi