Contract Regulatory Operations Publisher
Location: Remote – UK & Europe (England, Ireland, France, Northern Ireland, Scotland, Spain, Switzerland, Wales)
Duration: 12-month contract
We are currently supporting a global life sciences organization that is looking to bring on an experienced Contract Regulatory Operations Publisher to support regulatory submission activities during periods of surge or overflow workload.
Key Responsibilities:
* Perform document-level publishing and pre-publishing activities for regulatory submissions
* Ensure documents meet global health authority publishing standards (e.g., FDA, EMA, MHRA, Health Canada, SwissMedic)
* Format and troubleshoot complex regulatory documents within Microsoft Word
* Utilize Adobe Acrobat Professional with DXC (ISI) Toolbox for document preparation and publishing tasks
* Conduct quality control checks on published documents prior to submission
* Support regulatory teams during peak submission periods or overflow workload
Requirements:
* 5+ years of document-level publishing experience within a pharmaceutical, biotechnology, or CRO environment
* Strong expertise with Adobe Acrobat Professional
* Advanced Microsoft Word formatting and troubleshooting skills
* Proven experience ensuring publishing compliance with global regulatory authority standards
* Strong document-level publishing QC experience
* Experience with submission-level publishing tools, such as:
* Extedo eCTD Manager
* DocuBridge
* Global Submit
* or similar platforms
* Must have access to a personal laptop with Adobe Acrobat Professional installed
* Experience with DXC (ISI) Toolbox