Senior Director Regulatory Affairs

subrosa Health & Capital group; Italia; Presencial; EUR 180 000 - 240 000; Tempo integral

Resumo da oferta

subrosa Health & Capital group seeks a highly experienced Senior Director Regulatory Affairs (F/M/X) to lead regulatory strategy and operations in Italy, supporting an oncology launch. You will provide strategic guidance across projects, ensure compliance with Italian/EU regulations, and collaborate with global and European regulatory teams.

The role requires 10+ years in regulatory leadership, strong knowledge of Italian/EU frameworks, and oncology experience is preferred.

Qualificações

• Master’s or PhD in a scientific or medical discipline.
• 10+ years of regulatory leadership experience in pharma/biotech.
• Strong knowledge of Italian and EU regulatory frameworks.
• Oncology experience preferred.
• Excellent communication in Italian and English.
• Willingness to travel up to 30%.

Responsabilidades

• 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.

Conhecimentos

Regulatory leadership

Italian regulatory knowledge

English communication

Stakeholder engagement

Strategic leadership

Formação académica

Master’s or PhD in scientific or medical discipline

Descrição da oferta de emprego

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 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%