Senior Director Regulatory Affairs

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

Descrizione del lavoro

Subrosa Health & Capital Group in Varese, Lombardy, IT, seeks a Senior Director Regulatory Affairs to lead regulatory strategy for Italy and support oncology launch prep. You will guide compliance with Italian/EU regulations and collaborate with global teams.

Responsibilities include leading all Italian regulatory activities, driving consultations with authorities, overseeing labeling and promotions, monitoring regulatory developments, and shaping the RA organization’s strategic direction.

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 skills in Italian and English.
• Able 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 affairs

Italian language

English language

Strategic thinking

Formazione

Master's or PhD in scientific/medical field

Descrizione del lavoro

Senior Director Regulatory Affairs subrosa Health & Capital group Varese, Lombardy, 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 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%

Interested or know someone who might be a strong fit?

I would be delighted to connect for a confidential conversation