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JV

Janneke van Ulse

Submission Technical Expert @ Janssen Biologics
Netherlands

A Regulatory Operations Professional with more than 15 years’ experience working in the Netherlands, UK, Switzerland, and Belgium. A creative thinker with highly developed technical skills focused on quality support to clients. Flexible with good team working skills and ability to prioritize and deliver on time and to a high quality.

Tech stack

Systems

SharePoint
Microsoft 365 / Office 365

Cloud

Cloud

Miscellaneous

APIs

Enterprise Tools

Documentum

ETL Datawarehouse

DataStage
Language
Fluent English
English
Fluent
Dutch
Fluent
Work experience
Since 2015
Submission Technical Expert @ Janssen Biologics
01 January 2021 - 31 December 2023

Support current electronic document management and publishing tools, troubleshoot and provide first-line support to the Publishing team, monitor electronic publishing requirements and determine the scope for tool maintenance/development.

Regulatory Publisher/Submission Specialist @ Janssen Biologics, UCB, CSL Behring, Ipsen, Reckitt and Benckiser
01 January 2008 - 31 December 2020

Publishing various formats (paper and electronic) required by Health Authorities (EU, AU, CH, US, CA, GCC). Support functions on regulatory requirements, creating Submission Ready Documents (formatting).

Regulatory Operations Officer @ Galapagos
01 April 2017 - 31 August 2018

Operational execution and tracking of submission packages with various regulatory content, publishing and QC of regulatory documents, operational support to trial management metrics processes.

Submission Assistant Project Edge @ GSK
01 July 2015 - 31 March 2016

Authoring Support and Submission support provided to a CMC Compliance Project, coordinating workload and support team on regulatory requirements.

Education experience
Since 1980
Art History @ Leiden University
01 January 2000 - 01 January 2003

Study of art history.

Museum Studies @ Reinwardt Academie
01 January 1998 - 01 January 2000

Education of professionals to work in museums.

General Education @ Carolus Clusius College
01 January 1980 - 01 January 1985

Completed secondary education.

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