Regulatory Affairs Artwork Specialist
Pubblicato il 04-08-2026 - Altro in Roma
Who We Are
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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.
Values
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 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 Overview
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.
Key Responsibilities
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.
Key tasks include:
Supporting dossier preparation and submission activities
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
Handling End of Procedure (EoP) communications with AIFA
Managing national implementation of variations under the “Silenzio/Assenso” procedure
Overseeing publication of regulatory updates in the Italian Official Gazette
Managing Farmastampati processes
Ensuring accurate maintenance of the XEVMPD database
Education
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 xysqume for packaging materials (cartons, labels, PILs)
Language Skills
Native or fluent Italian
Good command of English
Technical Skills
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)
Core Competencies
Strong attention to detail and accuracy
Excellent organizational and planning skills
Effective communication and interpersonal abilities
Results-oriented with a proactive mindset
High level of integrity and strong work ethic
Location
Location Milan, Italy (Italian Affiliate of Sun Pharma)
Hybrid working model: 2 days in the office
Regulatory Affairs Artwork Specialist Rome, Italy
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