Manager, Regulatory Operations (eCTD Publishing)
This can be offered remote from the U.K.
A clinical-stage biotech is expanding its EU team following significant growth and is looking to hire a Manager, Regulatory Operations to support global submissions across a robust oncology pipeline.
This is a hands-on role focused on eCTD publishing, submission management, and regulatory operations.
Key Responsibilities
* Lead and support eCTD publishing for INDs, NDAs, CTAs, MAAs
* Prepare, compile, QC, and submit dossiers to FDA and global health authorities
* Manage submission timelines and ensure compliance with regulatory standards (FDA/EMA)
* Collaborate with cross-functional teams to deliver high-quality submissions
* Maintain submission tracking, templates, and regulatory documentation
* Support development of SOPs and regulatory operations processes
Requirements
* 5+ years in Regulatory Operations / eCTD publishing
* Strong experience building and submitting IND/NDA applications
* Hands-on with tools such as eCTDXpress, Lorenz, Liquent
* Solid understanding of global submission requirements
* Ability to operate in a fast-paced, deadline-driven environment
Why This Role?
* High-impact role within a growing biotech
* Strong pipeline in oncology
* Exposure to global submissions and cross-functional teams
* Competitive package + bonus