Regulatory Affairs Artwork Specialist
Pubblicato il 01-08-2026 - SUN PHARMA in Bardi
Who We Are
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 ****** 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 motivatedRegulatory Affairs Artwork Specialistwith 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 withnew Marketing Authorizations (MAs)and lifecycle management of products registered viaMRP, DCP, and CP procedures.
Key tasks include:
Supporting dossier preparation and submission activities
ManagingProduct Operating Licenses (POL)assignment
Coordinatingartwork creation, review, and approval(carton boxes, labeling, and PILs)
Maintaining and updating national regulatory databases
Submitting applications viaAIFA Front End / CESPplatforms
HandlingEnd of Procedure (EoP)communications with AIFA
Managing national implementation of variations under the "Silenzio/Assenso" procedure
Overseeing publication of regulatory updates in theItalian Official Gazette
ManagingFarmastampatiprocesses
Ensuring accurate maintenance of theXEVMPD 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 inartwork preparation and reviewfor packaging materials (cartons, labels, PILs)
Language Skills
Native or fluentItalian
Good command ofEnglish
Technical Skills
Strong knowledge ofQRD templatesandBlue Box requirements
Proficiency in Microsoft Office (Excel, Word, PowerPoint) and PDF tools
Familiarity withAIFA Front Endand 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
?Milan, Italy(Italian Affiliate of Sun Pharma)
? Hybrid working model:2 days in the office