Senior Director Regulatory Affairs

Subrosa Health & Capital Group; Belluno; In loco; EUR 150.000 - 210.000; Tempo pieno

Descrizione del lavoro

subrosa Health & Capital group seeks a Senior Director Regulatory Affairs to lead Italy's regulatory strategy and operations, supporting an oncology launch. You will partner with global teams, guide pre‑submission activities, and ensure EU/Italian compliance while shaping the RA organization.

You will interact with authorities, manage labeling and promotional materials, and travel up to 30% to support regional initiatives in a fast-paced, innovative biotech environment.

Competenze

• 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.

Mansioni

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

Conoscenze

Regulatory leadership

Italian

English

Stakeholder communication

Travel willingness

Formazione

Master’s or PhD in scientific/medical discipline

Descrizione del lavoro

Senior Director Regulatory Affairs subrosa Health & Capital group belluno, veneto, it

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%