Regulatory Affairs - Regional Dossier Publisher

Job Description

The Regional Dossier Publisher (RDP) will work within the Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the EU+EEMEA Regulatory Operations (RRO-EU+EEMEA) Team.

The RDP is responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by our regional publishing team who are working on dossiers for the regions.  The RDP will have a good knowledge of the regulatory procedures and dossier requirements in the regions and be able to apply this to the publishing processes and tools to ensure that the submissions delivered to the Country RA groups meet their specific needs.

The RDP will also be involved with supporting Country RA teams with their local publishing and submission transmission needs and ensure they can meet their submission deadlines.  The role will assist HQ Colleagues within RPP in the development of the tools and procedures that support our submission publishing procedures

Primary Activities include but are not limited to:

The RDP will be the regional expert for regulatory submission capabilities, including dossier structures and file formats, electronic submissions, and transmission (e.g., agency gateways), dossier repositories and databases.

The RDP will be responsible for identifying and maintaining dossier format requirements supporting regulatory dossier assembly (aka publishing) and delivery to regulatory health authorities or to the country organization in the region.

The RDP will support the maintenance of related processes in accordance with regional/country requirements and will support the central publishing team responsible for the execution of the assembly processes.

The RDP will play an advocating role for standardization across the supported countries within the region.

The RDP will lead technical impact assessments of regional/country requirements for regulatory submissions and serve as the technical expert for local Country RA teams and providing training to the Country RA teams on the publishing processes.

The RDP will serve as the technical expert and point of contact for health/regulatory authorities in the region

The RDP will support the maintenance of processes and systems related to the assembly and delivery of regulatory submissions.

The RDP will also perform publishing in executing the assembly and delivery processes to meet critical submission targets.

The RDP will participate to “Improvement process and tools project” by taking part of system testing, performance measures and other efforts necessary for readiness.

The RDP will support the technical validation process.

The RDP will play a role as Mentor/Coach/Manage external sources publishers.

Profile:

Minimum 3 years publishing experience

Knowledge in Ennov Insight Publisher and/or Lorenz Docubridge, knowledge of other publishing tools will be considered as a plus.

Strong analytical and customer service skills with the ability to work with varying grade levels, educational background, and departments.

Demonstrated ability to work under tight deadlines.

Proven attention to detail and ability to work with a variety of technical applications.

Working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project) and Document Management systems.

Knowledge of publishing requirements in the EU and EEMEA regions.

Knowledge of the regulatory registration procedures in the EU and EEMEA regions will be considered as a plus.