Global Regulatory Publishing Executive

MENARINI Group; Toscana; Hybrid; EUR 97,000 - 104,000; Full time

Job summary

Menarini Group in Florence seeks a Head of Global Regulatory Publishing to own the global publishing strategy, technical submissions operations, and electronic document infrastructure across therapeutic areas. You will lead a global team and shape the regulatory publishing operating model.

The role requires deep expertise in global electronic submissions and Regulatory Affairs, partnering with regional leads, and managing external vendors. Hybrid work with on-site Florence 1–2 days weekly.

Qualifications

• Advanced degree in Life Sciences, Regulatory Science or related field.
• 10+ years in international regulatory affairs or global regulatory operations in pharma.
• 6+ years leading Global Regulatory Publishing and Electronic Submissions.

Responsibilities

• Design and lead the global operating model for Regulatory Publishing across HQ, regional hubs, local affiliates and service providers.
• Oversee end-to-end technical compilation, formatting, QC, validation and dispatch of electronic submissions worldwide.
• Set KPIs, metrics and quality standards for submission readiness and editorial accuracy.
• Evaluate and maintain regulatory publishing applications (Veeva Vault Submissions/Publishing, LORENZ docuBridge).
• Drive readiness for eCTD v4.0, IDMP data standards and automated publishing workflows.
• Collaborate with Regulatory Leads and cross-functional teams for submission planning.
• Manage external publishing vendors and budget, ensuring SLAs and performance.
• Ensure compliance with international health authority requirements and GxP.
• Mentor and develop publishing and operations professionals.

Skills

Regulatory publishing leadership

GxP compliance

Veeva Vault Submissions/Publishing

LORENZ docuBridge

eCTD standards

Vendor & stakeholder management

English proficiency

Education

Advanced degree in Life Sciences or related

Tools

LORENZ docuBridge

eCTD validation tools

Veeva Vault Submissions/Publishing

Job description

Menarini Group in Florence seeks a Head of Global Regulatory Publishing to own the global publishing strategy, technical submissions operations, and electronic document infrastructure across therapeutic areas. You will lead a global team and shape the regulatory publishing operating model.

The role requires deep expertise in global electronic submissions and Regulatory Affairs, partnering with regional leads, and managing external vendors. Hybrid work with on-site Florence 1–2 days weekly.