We are looking for a new Valesta consultant that is eager to start at a global regulatory affairs department. We are looking for someone with:
- At least 3 years of Submission publishing experience (eCTD) and knowledge of the publishing requirements in the EMEA region
- A good level of English
- Strong analytical and customer service skills
The Regional Dossier Publisher (RDP) will work within the Global Regulatory Affairs and Clinical Safety (GRACS) organization, in the Regulatory Affairs Operations Europe, Middle east and Africa (RAO-EMEA) department in Belgium. The RDP is responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by our decentralised publishing team who are working on dossiers for the region. The RDP will have a good knowledge of the regulatory procedures and requirements in the region 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 publisher will execute the assembly and delivery processes, in particular to meet critical submission targets. 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.
- Ensure readiness of the assembly and delivery related systems and toolsets for the region (publishing system, validation tools, media creation (e.g. CD, DVD). Participate in system testing, performance measures and other efforts necessary for readiness.
- Support the Central Publishing Team in understanding and applying the regional/local regulatory dossiers requirements.
- Execute the assembly and delivery process, when necessary, to meet submission targets.
- Support the technical validation process. Support the region adopting global or established standards in the regulatory submissions area.
- Bachelors degree or equivalent in life sciences, business, IT, or other related discipline
- Good level of English
- Minimum 3 years publishing experience with Liquent Insight Publisher, knowledge of other publishing tools will be considered as a plus.
- Submission Publishing experience is a must (eCTD).
- Knowledge of publishing requirements in the EMEA region, particularly the requirements in the EU.
- Knowledge of the regulatory registration procedures in the EMEA region 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.
- Excellent interpersonal skills and oral and written communication skills.
- Demonstrated ability to work under tight deadlines.
- Proven attention to detail and ability to work with a variety of technical applications.
- Strong knowledge of the English language.
- Working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project, Documentum)
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