Regulatory Affairs Manager (Maternity Cover)

We are hiring a Regulatory Affairs Manager for a maternity cover on a 8-12 months fixed term contract/full time. The primary responsibilities include providing regulatory input to projects, managing regulatory submissions, tracking submissions and approvals, and serving as a key regulatory liaison for multi-continental projects.

Requirements

• Bachelor's degree in a life science field or equivalent
• 4+ years of EU regulatory experience in the pharmaceutical industry
• Direct experience of CTIS and IRAS CTA preparations and submissions
• Prior experience in a CRO environment preferred
• Experience from national applications such as GMO, radiation safety is preferred