Regulatory Affairs Artwork Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79r190

Who We AreLe seguenti informazioni forniscono una panoramica delle competenze, delle qualità e delle qualifiche necessarie per questo ruolo.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 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.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.ValuesAt Sun Pharma our core values—Humility, Integrity, Passion, and Innovation—are part of our unique culture, known as Sunology.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.Role OverviewWe 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.Key ResponsibilitiesThe 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.Key tasks include:Supporting dossier preparation and submission activitiesManaging Product Operating Licenses (POL) assignmentCoordinating artwork creation, review, and approval (carton boxes, labeling, and PILs)Maintaining and updating national regulatory databasesSubmitting applications via AIFA Front End / CESP platformsHandling End of Procedure (EoP) communications with AIFAManaging national implementation of variations under the "Silenzio/Assenso" procedureOverseeing publication of regulatory updates in the Italian Official GazetteManaging Farmastampati processesEnsuring accurate maintenance of the XEVMPD databaseEducationDegree in Life Sciences or a related field (preferred)Professional Experience1–2 years of experience in a Regulatory Affairs department within the pharmaceutical industryPractical xdwybme experience in artwork preparation and review for packaging materials (cartons, labels, PILs)Language SkillsNative or fluent ItalianGood command of EnglishTechnical SkillsStrong knowledge of QRD templates and Blue Box requirementsProficiency in Microsoft Office (Excel, Word, PowerPoint) and PDF toolsFamiliarity with AIFA Front End and submission systemsExperience with virtual collaboration tools (e.g. Microsoft Teams, GoToMeeting)Core CompetenciesStrong attention to detail and accuracyExcellent organizational and planning skillsEffective communication and interpersonal abilitiesResults-oriented with a proactive mindsetHigh level of integrity and strong work ethicLocationMilan, Italy (Italian Affiliate of Sun Pharma)Hybrid working model: 2 days in the office

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79r190