Senior Director Regulatory Affairs

Subrosa Health & Capital Group; Siena; In loco; EUR 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

Subrosa Health & Capital Group cerca un Senior Director Regulatory Affairs (F/M/X) con ampia esperienza per guidare la strategia regolatoria in Italia e supportare lo sviluppo di lanci oncologici promettenti.

Il ruolo prevede leadership, conformità ai regolamenti italiani ed EU, stretta collaborazione con team globali e gestione di processi, audit e ispezioni. Si richiede disponibilità a viaggi fino al 30% e eccellenti capacità comunicative in italiano e inglese.

Competenze

• Laurea magistrale o PhD in una disciplina scientifica o medica.
• Alto livello di leadership regolatoria e esperienza in pharma/biotech.
• Ottime capacità comunicative in italiano e inglese.

Mansioni

• Guidare tutte le attività regolatorie in Italia in allineamento con normative nazionali ed EU.
• Guidare consultazioni scientifiche, meeting pre‑submission e interazioni con le autorità italiane.
• Supervisionare etichettatura, packaging, revisione material di promozione e comunicazione HCP.
• Monitorare sviluppi regolatori italiani e comunicare implicazioni ai team globali.
• Rappresentare Regulatory Affairs internamente ed esternamente; contribuire ad associazioni di settore.
• Guidare e ottimizzare processi regolatori, SOP, audit, ispezioni e conformità.
• Gestire difetti di qualità, richiami e licenze regolatorie.
• Fornire leadership, pianificazione risorse e direzione strategica per l’organizzazione RA italiana.

Conoscenze

Regulatory leadership

Inglese

Italiano

Formazione

Laurea magistrale/PhD

Descrizione del lavoro

Descrizione dell’offerta di lavoro For an innovative international biotechnology company, we are currently looking for an highly experienced Senior Director Regulatory Affairs (F/M/X) to lead the regulatory strategy and operations in Italy and support the preparation of a highly promising oncology launch.

The Opportunity: The role provides strategic guidance across assigned projects, ensures full compliance with Italian/EU regulations, and collaborates closely with global and European regulatory teams supporting both early‑stage and marketed products. As part of the local Management Team, the Senior Director works cross‑functionally with medical affairs, clinical development, marketing, and other key functions.

Key Responsibilities:

• Lead all regulatory activities for Italy in alignment with national and EU requirements
• Drive scientific consultations, pre‑submission meetings, and interactions with Italian authorities
• Oversee labeling, packaging, promotional material review, and HCP communication
• Monitor Italian regulatory developments and communicate implications to global teams
• Represent Regulatory Affairs internally and externally; contribute to industry associations
• Lead and optimize regulatory processes, SOPs, audits, inspections, and compliance
• Manage quality defects, recalls, and regulatory licenses
• Provide leadership, resource planning, and strategic direction for the Italian RA organization

Required Qualifications:

• Master's or PhD in a scientific or medical discipline
• 10+ years of regulatory leadership xlwpduy experience in pharma/biotech
• Strong knowledge of Italian and EU regulatory frameworks
• Oncology experience preferred
• Excellent communication skills in Italian and English
• Proven ability to analyze scientific information and engage effectively with authorities
• Ability to thrive in a dynamic, fast‑paced environment; willingness to travel up to 30%