Regulatory Manager Operations

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

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