Head of Global Regulatory Publishing

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

Our client is Menarini Group, a leading international pharmaceutical and healthcare company, present in 140 countries worldwide with over 17,500 employees, with a long-standing commitment to innovation, scientific excellence and improving patients’ lives.

As part of the continued evolution of its Global R&D and Global Regulatory Affairs organization, Menarini is looking for a

Head of Global Regulatory Publishing

to join its Global Regulatory Affairs Operations team.

Reporting directly to the Head of Global Regulatory Affairs Operations, the role will take full ownership of the global regulatory publishing strategy, technical submission operations and electronic document publishing infrastructure across Menarini Group therapeutic areas.

The successful candidate will combine deep technical expertise in global electronic submissions with strong knowledge of Regulatory Affairs and Regulatory Operations, leading a global team and contributing to the evolution of Menarini’s regulatory operating model.

Key Responsibilities

• Design, build, and lead the global operating model for Regulatory Publishing across HQ, regional hubs, local affiliates, and external service providers.
• Oversee the end-to-end technical compilation, formatting, quality control, validation, and dispatch of electronic regulatory submissions to Health Authorities worldwide.
• Establish key performance indicators (KPIs), operational metrics, and quality standards for submission readiness, compilation velocity, and technical error rates.
• Lead the evaluation, implementation, validation, and maintenance of regulatory publishing applications (e.g., Veeva Vault Submissions/Publishing, LORENZ docuBridge).
• Drive organizational readiness and technical transition to eCTD v4.0, IDMP data standards, and automated publishing workflows.
• Build collaborative relationships with Global/Regional Regulatory Leads and cross-functional teams, ensuring effective submission planning and execution.
• Oversee strategic partnerships with external publishing service providers, CROs, and software vendors, including SLAs, performance, and budget management.
• Ensure compliance with international Health Authority requirements, global SOPs, GxP, and electronic record regulations.
• Lead, mentor, and develop regulatory publishing and operations professionals, fostering technical excellence and continuous improvement.

Qualifications, Experience & Skills

• Advanced Degree (Ph.D., PharmD, M.S., or equivalent) in Life Sciences, Computer Science, Regulatory Science, or a related discipline.
• 10+ years of progressive experience in International Regulatory Affairs and/or Global Regulatory Operations within the pharmaceutical or biopharmaceutical industry.
• Proven track record (6+ years) in a direct leadership role overseeing Global Regulatory Publishing and Electronic Submissions.
• Direct operational experience in compiling and publishing major global regulatory applications (e.g., NDAs, BLAs, MAAs, INDs, CTAs).
• Deep expertise with regulatory publishing systems, including Veeva Vault Submissions/Publishing, LORENZ docuBridge, and eCTD validation tools.
• Strong matrix leadership, vendor management, analytical, and problem-solving skills.
• Excellent command of written and spoken English. Working knowledge of Italian or other European languages is an advantage.

Working Model: Hybrid – On-site presence in Florence required 1–2 days per week.

What Menarini offers

The position provides the opportunity to play a key role in the continued development of Menarini’s Global Regulatory Affairs organization, contributing directly to the transformation of its global regulatory publishing capabilities.

Salary range: €97,000 – €104,000 gross annual base salary, depending on the candidate’s experience, seniority and overall fit with the role.

The Menarini Group is committed to equal opportunities and an inclusive working environment. The search is open to all qualified candidates, without discrimination on the basis of sex, gender identity or expression, sexual orientation, age, disability, nationality, ethnic origin, religion or belief, marital or family status, or any other characteristic protected by applicable law.