31 lug
|
SUN PHARMA
|
Turbigo
31 lug
SUN PHARMA
Turbigo
ppSun 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 40.000 employees around the globe, we provide high‑quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. /p pOver 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. /p h3Values /h3 pAt Sun Pharma our core values—Humility, Integrity, Passion, and Innovation—are part of our unique culture, known as Sunology. /p pWe 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. /p h3Role Overview /h3 pWe are seeking a motivated bRegulatory Affairs Artwork Specialist /b 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. /p h3Key Responsibilities /h3 pThe selected candidate will be responsible for managing regulatory and artwork activities associated with bnew Marketing Authorizations (MAs) /b and lifecycle management of products registered via bMRP, DCP, and CP procedures /b.
/p pKey tasks include: /p ul liSupporting dossier preparation and submission activities /li liManaging bProduct Operating Licenses (POL) /b assignment /li liCoordinating bartwork creation, review, and approval /b (carton boxes, labeling, and PILs) /li liMaintaining and updating national regulatory databases /li liSubmitting applications via bAIFA Front End / CESP /b platforms /li liHandling bEnd of Procedure (EoP) /b communications with AIFA /li liManaging national implementation of variations under the “Silenzio/Assenso” procedure /li liOverseeing publication of regulatory updates in the bItalian Official Gazette /b /li liEnsuring accurate maintenance of the bXEVMPD database /b /li /ul h3Education /h3 ul liDegree in Life Sciences or a related field (preferred) /li /ul h3Professional Experience /h3 ul li1–2 years of experience in a Regulatory Affairs department within the pharmaceutical industry /li liPractical experience in bartwork preparation and review /b for packaging materials (cartons, labels, PILs) /li /ul h3Language Skills /h3 ul liNative or fluent bItalian /b /li liGood command of bEnglish /b /li /ul h3Technical Skills /h3 ul liStrong knowledge of bQRD templates /b and bBlue Box requirements /b /li liProficiency in Microsoft Office (Excel, Word, PowerPoint) and PDF tools /li liFamiliarity with bAIFA Front End /b and submission systems /li liExperience with virtual collaboration tools (e.g. Microsoft Teams, GoToMeeting) /li /ul h3Core Competencies /h3 ul liStrong attention to detail and accuracy /li liExcellent organizational and planning skills /li liEffective communication and interpersonal abilities /li liResults‑oriented with a proactive mindset /li liHigh level of integrity and strong work ethic /li /ul h3Location /h3 pbMilan, Italy /b (Italian Affiliate of Sun Pharma) /p pHybrid working model: b2 days in the office /b /p /p #J-18808-Ljbffr
📌 Regulatory Affairs Artwork Specialist (Turbigo)
🏢 SUN PHARMA
📍 Turbigo