Regulatory Affairs - Regional Dossier Publisher

2 Locationsmid

Legal & ComplianceRegulatory

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Quick Summary

Overview

Job Description As a Regional Dossier Publisher, you will: Serve as the regional subject matter expert for regulatory submission publishing, including dossier structures, file formats,

Technical Tools

Legal & ComplianceRegulatory

Job Description

Serve as the regional subject matter expert for regulatory submission publishing, including dossier structures, file formats, electronic submissions, transmission gateways, and dossier repositories.
Identify, maintain, and apply dossier format requirements to support the assembly and delivery of regulatory submissions to health authorities and country organizations.
Support country Regulatory Affairs teams with local publishing and submission transmission needs to help ensure critical deadlines are met.
Collaborate with central publishing teams to maintain and execute publishing processes in line with regional and country requirements.
Promote standardization across supported countries and encourage consistent publishing practices.
Lead technical impact assessments for regional and country regulatory submission requirements.
Provide technical guidance and training to country Regulatory Affairs teams on publishing processes and tools.
Act as a technical point of contact for health and regulatory authorities in the region.
Support the maintenance and validation of processes and systems related to regulatory submission assembly and delivery.
Perform publishing activities to meet key submission timelines.
Participate in improvement projects, including system testing, readiness activities, and performance measurement initiatives.
Support technical validation efforts.
Mentor, coach, and manage external publishing resources as needed.

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 is required.
Knowledge of regulatory registration procedures in the EU and EEMEA is considered a plus.

MS Office applications
Adobe Acrobat
MS Project
Document Management Systems
Proven ability to work with a variety of technical applications and publishing systems.
Familiarity with dossier assembly, electronic submission formats, and submission transmission tools.

Strong analytical skills and attention to detail.
Excellent customer service and communication skills.
Ability to work effectively with stakeholders at different levels and across departments.
Proven ability to work under pressure and meet tight deadlines.
Strong organizational skills and a proactive, solution-oriented mindset.

What We Offer

~1 min read

✓A dynamic role within a highly collaborative regulatory operations environment.

✓The opportunity to work on important regional submission activities across EU+EEMEA.

✓Exposure to a broad range of regulatory publishing processes, systems, and improvement initiatives.

✓The chance to contribute to standardization, technical readiness, and continuous improvement efforts.

✓Opportunities to support, train, and mentor colleagues and external resources.

✓A role with meaningful impact on the timely delivery of critical regulatory submissions.

Adaptability, Adaptability, Audits Compliance, Claims Settlement, Critical Thinking, Detail-Oriented, Document Management, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Liaison Work, Office Automation, Performance Improvements, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Proactive Thinking, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Documents, Regulatory Management, Regulatory Operations, Regulatory Processes, Regulatory Reporting {+ 6 more}