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
Proven ability to work with a variety of tech
📌 Regulatory Affairs (Hyderabad)
🏢 Msd
📍 Hyderabad