Deutschland - Senior Start Up Specialist

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We are looking for a Senior Start Up Specialist to be based in any UK or German office.The Senior Start Up Specialist is an expert on regulatory and ethics processes and documentation requirements for the start-up and maintenance of Clinical Trial Authorisations. Core Responsibilities The Senior Regulatory Specialist takes on the following roles, as and when required:In-Country Regulatory Lead• Develops submissions strategy for Clinical Trial Authorisation Applications on assigned project• Provides strategic level advice on regulatory issues to Sponsor and Project Leader• Develops the Regulatory Plan, essential document management plan, and project specific checklists• Responsible for the preparation of core initial submission packages for CA and EC submissions, including required scientific and technical supporting data for EMEA region (e.g. IMPD).• Prepares project-specific core essential document templates/binders• Reviews and ensures compliance of core SIS/ICF with CFR, GCP and local requirements, as applicable• Coordinates drug label review, adaptation, translation and compliance • Active management of CA and EC submissions • Creates and maintains project level study-tracking solutions• Coordinates regulatory translations and version control• Acts as co ...

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