Regulatory Affairs Regional Dossier Publisher

About the role

The Regional Dossier Publisher acts as the subject‑matter expert for regulatory submission publishing across the EU and EEMEA region. You will support country Regulatory Affairs teams, ensure compliance with dossier formats, and help meet critical submission deadlines.

Key responsibilities

• Maintain and apply dossier format requirements for electronic submissions and transmission gateways.
• Support country teams with local publishing, transmission, and technical guidance.
• Collaborate with central publishing teams to standardise processes and ensure regional compliance.
• Lead technical impact assessments and provide training on publishing tools.
• Act as the technical point of contact for health authorities in the region.
• Participate in improvement projects, system testing, and performance measurement initiatives.

Required profile

• Minimum 4 years of publishing experience in regulatory submissions.
• Hands‑on experience with Ennov Insight Publisher and/or Lorenz Docubridge.
• Experience supporting EU and EEMEA publishing requirements.
• Strong analytical, organisational, and customer‑service skills.
• Ability to work under pressure and meet tight deadlines.

Required skills

• Ennov Insight Publisher
• Lorenz Docubridge
• MS Office applications
• Adobe Acrobat
• MS Project
• Document Management Systems

What we offer

• A dynamic role within a collaborative regulatory operations environment.
• Opportunity to work on regional EU+EEMEA submission activities.
• Exposure to a broad range of publishing processes, systems, and improvement initiatives.
• Opportunities to mentor, train, and support colleagues and external resources.