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, 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.
Required Experience and Skills
Experience:
• 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.
Technical Skills:
• MS Office applications
• Adobe Acrobat
• MS Project
• Document Management Systems
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📌 Regulatory Affairs (Hyderabad)
🏢 Msd
📍 Hyderabad