Regulatory Affairs Specialist settore farmaceutico

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b0a9i

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.

At 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 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.



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 .

Managing Product Operating

Licenses (POL) assignment Coordinating artwork creation, review, and approval (carton boxes, labeling, and PILs) Maintaining and updating national regulatory databases Submitting applications via AIFA Front End / CESP platforms Managing national implementation of variations under the “Silenzio/Assenso” procedure Overseeing publication of regulatory updates in the Italian Official Gazette Ensuring accurate maintenance of the XEVMPD database Degree in Life Sciences or a related field (preferred) Professional Experience ~1–2 years of experience in a Regulatory Affairs department within the pharmaceutical industry ~ Practical experience in artwork preparation and review for packaging materials (cartons, labels, PILs) Language Skills Native or fluent Italian Good command of English Strong knowledge of QRD templates and Blue Box requirements Proficiency in Microsoft Office (Excel, Word, PowerPoint) and PDF tools Familiarity with AIFA Front End and submission systems Experience with virtual collaboration tools (e.g.

Microsoft

Teams, GoToMeeting) Excellent organizational and planning skills High level of integrity and strong work ethic Milan, Italy (Italian Affiliate of Sun Pharma) Hybrid working model: 2 days in the office

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b0a9i