Regulatory Affairs Artwork Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ak682

pstrongWho We Are /strong /ppbr / /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. /ppOver 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. /ppstrongValues /strong /ppbr / /ppAt Sun Pharma our core values—Humility, Integrity, Passion, and Innovation—are part of our unique culture, known as Sunology. /ppbr / /ppWe 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. /ppbr / /ppbr / /ppstrongRole Overview /strong /ppbr / /ppWe are seeking a motivated strongRegulatory Affairs Artwork Specialist /strong 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. /ppbr / /ppstrongKey Responsibilities /strong /ppbr / /ppThe selected candidate will be responsible for managing regulatory and artwork activities associated with strongnew Marketing Authorizations (MAs) /strong and lifecycle management of products registered via strongMRP, DCP, and CP procedures /strong. /ppbr / /ppKey tasks include:



/ppbr / /pulliSupporting dossier preparation and submission activities /liliManaging strongProduct Operating Licenses (POL) /strong assignment /liliCoordinating strongartwork creation, review, and approval /strong (carton boxes, labeling, and PILs) /liliMaintaining and updating national regulatory databases /liliSubmitting applications via strongAIFA Front End / CESP /strong platforms /liliHandling strongEnd of Procedure (EoP) /strong communications with AIFA /liliManaging national implementation of variations under the em“Silenzio/Assenso” /em procedure /liliOverseeing publication of regulatory updates in the strongItalian Official Gazette /strong /liliManaging strongFarmastampati /strong processes /liliEnsuring accurate maintenance of the strongXEVMPD database /strong /li /ulpbr / /ppstrongEducation /strong /ppbr / /pulliDegree in Life Sciences or a related field (preferred) /li /ulpbr / /ppstrongProfessional Experience /strong /ppbr / /pulli1–2 years of experience in a Regulatory Affairs department within the pharmaceutical industry /liliPractical experience in strongartwork preparation and review /strong for packaging materials (cartons, labels, PILs) /li /ulpbr / /ppstrongLanguage Skills /strong /ppbr / /pulliNative or fluent strongItalian /strong /liliGood command of strongEnglish /strong /li /ulpbr / /ppstrongTechnical Skills /strong /ppbr / /pulliStrong knowledge of strongQRD templates /strong and strongBlue Box requirements /strong /liliProficiency in Microsoft Office (Excel, Word, PowerPoint) and PDF tools /liliFamiliarity with strongAIFA Front End /strong and submission systems /liliExperience with virtual collaboration tools (e.g. Microsoft Teams, GoToMeeting) /li /ulpbr / /ppstrongCore Competencies /strong /ppbr / /pulliStrong attention to detail and accuracy /liliExcellent organizational and planning skills /liliEffective communication and interpersonal abilities /liliResults-oriented with a proactive mindset /liliHigh level of integrity and strong work ethic /li /ulpbr / /ppstrongLocation /strong /ppbr / /pp strongMilan, Italy /strong (Italian Affiliate of Sun Pharma) /pp Hybrid working model: strong2 days in the office /strong /p

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ak682