Regulatory Affairs Artwork Specialist (Milano)

Regulatory Affairs Artwork Specialist (Milano)

04 ago
|
SUN PHARMA
|
Milano

04 ago

SUN PHARMA

Milano

pstrong Who We Are /strongp Per una comprensione completa di questa occasione e dei requisiti per essere un candidato di successo, continui a leggere.
brp 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.
/pp 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.
/ppstrong Values /strong /p p At Sun Pharma our core values—Humility, Integrity, Passion, and Innovation—are part of our unique culture, known as Sunology.
/p p 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.




/p pstrong Role Overview /strong /p p We are seeking a motivated strong Regulatory Affairs Artwork Specialist /strong 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.
/p pstrong Key Responsibilities /strong /p p The selected candidate will be responsible for managing regulatory and artwork activities associated with strong new Marketing Authorizations (MAs) /strong and lifecycle management of products registered via strong MRP, DCP, and CP procedures /strong .
/p p Key tasks include: /p ulli Supporting dossier preparation and submission activities /lili Managing strong Product Operating Licenses (POL) /strong assignment /lili Coordinating strong artwork creation, review, and approval /strong (carton boxes, labeling, and PILs) /lili Maintaining and updating national regulatory databases /lili Submitting applications via strong AIFA Front End / CESP /strong platforms /lili Handling strong End of Procedure (EoP)



/strong communications with AIFA /lili Managing national implementation of variations under the "Silenzio/Assenso" procedure /lili Overseeing publication of regulatory updates in the strong Italian Official Gazette /strong /lili Managing strong Farmastampati /strong processes /lili Ensuring accurate maintenance of the strong XEVMPD database /strong /li /ul pstrong Education /strong /p ulli Degree in Life Sciences or a related field (preferred) /li /ul pstrong Professional Experience /strong /p ulli1–2 years of experience in a Regulatory Affairs department within the pharmaceutical industry /lili Practical experience in strong artwork preparation and review /strong for packaging materials (cartons, labels, PILs) xrdbqlu /li /ul pstrong Language Skills /strong /p ulli Native or fluent strong Italian /strong /lili Good command of strong English /strong /li /ul pstrong Technical Skills /strong /p ulli Strong knowledge of strong QRD templates /strong and strong Blue Box requirements /strong /lili Proficiency in Microsoft Office (Excel, Word, PowerPoint) and PDF tools /lili Familiarity with strong AIFA Front End /strong and submission systems /lili Experience with virtual collaboration tools (e.g. Microsoft Teams, GoToMeeting) /li /ul pstrong Core Competencies /strong /p ulli Strong attention to detail and accuracy /lili Excellent organizational and planning skills /lili Effective communication and interpersonal abilities /lili Results-oriented with a proactive mindset /lili High level of integrity and strong work ethic /li /ul pstrong Location /strong /p p strong Milan, Italy /strong (Italian Affiliate of Sun Pharma) /pp Hybrid working model: strong2 days in the office /strong /p /p /p

📌 Regulatory Affairs Artwork Specialist (Milano)
🏢 SUN PHARMA
📍 Milano

Candidati a questo annuncio

Mostra le tue capacità professionali all'azienda, compila il form e lascia un tocco personale nella lettera di presentazione, aiuterà il recruiter nella scelta del candidato.

Iscriviti a questa job alert:

Ricevi via email le nuove offerte di lavoro per: regulatory affairs artwork specialist (milano) / milano