Senior Director Regulatory Affairs

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

Descrizione del lavoro

Subrosa Health & Capital Group è alla ricerca di un Senior Director Regulatory Affairs per guidare la strategia regolatoria in Italia e supportare il lancio oncologico altamente promettente.

Garantirà le attività regolatorie italiane ed europee, coordinerà consultazioni scientifiche, riunioni pre‑sottomissione e interazioni con le autorità, supervisionando etichette, confezionamento e materiali promozionali.

Competenze

• Master's or PhD in una disciplina scientifica o medica.
• 10+ years of regulatory leadership experience in pharma/biotech.
• Strong knowledge of Italian and EU regulatory frameworks.
• Oncology experience preferred.
• Excellent communication skills in Italian and English.
• Willingness to travel up to 30%.

Mansioni

• 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.

Conoscenze

Regulatory leadership

Regulatory strategy

Team leadership

Communication

Project management

Formazione

Master's or PhD in scientific/medical discipline

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.

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%