Regulatory Submissions Coordinator Manager (Remote, Spain/Portugal/UK)

About the role

Syneos Health is seeking a Regulatory Submissions Coordinator Manager to support global regulatory submission projects. The role is remote and open to candidates located in Spain, Portugal, or the United Kingdom.

Key responsibilities

• Create and maintain content plans within Veeva Vault RIM.
• Translate Smartsheet timelines into Microsoft Project and Veeva Vault RIM.
• Assist Vertex Global Submission Managers with project management activities, tracking, and coordination of regulatory submissions.
• Support communication of regulatory submissions to Vertex Publishing and ensure adherence to firm deadlines.

Required profile

• B.S. (or equivalent) with 5+ years of Regulatory Affairs experience focused on publishing/submissions, or M.S. with 3+ years.
• In‑depth knowledge of FDA, EMA, and ICH regulatory requirements.
• Strong organizational and communication skills with attention to detail.

Required skills

• Veeva Vault RIM, Insight Publisher, Lorenz Publisher, DXC (ISI) Toolbox.
• eCTD submission tools and electronic submission software.
• Project management tools: Smartsheet, Microsoft Project, Excel, Office timeline.