Regulatory Affairs Artwork Specialist

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 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 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

Milan, Italy (Italian Affiliate of Sun Pharma)

Hybrid working model: 2 days in the office