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

About the role

Syneos Health is seeking a Regulatory Submissions Coordinator Manager to support global 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 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, ICH regulations and submission types (eCTD, NDA, IND, MAA, etc.).
• Excellent organization, written and verbal communication, and attention to detail.

Required skills

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