Associate/Director, EU Regulatory Affairs - Orleans, United States - NovaWorks Solutions

NovaWorks Solutions
NovaWorks Solutions
Verified Company
Orleans, United States

3 weeks ago

Meredith Sinclair

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Meredith Sinclair

beBee Recruiter
Description

Summary

The role is responsible for overseeing and delivering all Clinical Trial Applications (CTAs) outside of the US and Canada for development programs in Orleans. The candidate will be an active member of the Study Teams and ensure alignment across functions to submit and gain approval for CTAs on time and with high quality.

Responsibilities

  • Plan, execute, and oversee all ex-US/ex-Canada CTA submissions in line with program strategies and study team timelines
  • Collaborate closely with the internal Regulatory team to ensure excellent execution of all CTAs
  • Oversee and manage CRO contributions to CTAs and escalate any critical issues as needed
  • Ensure that CRO work orders and contracts are up to date to support CTA deliverables
  • Develop regulatory strategies and draft documents for submission to global health authorities and Ethics Committees related to CTAs
  • Lead internal and external stakeholders in responding to information requests from Competent Authorities regarding CTAs in a timely and high-quality manner
  • Serve as the internal expert on the EU Clinical Trial Directive/Regulation, including regulatory submission requirements and IVDR clinical submissions
  • Assess change controls related to CTAs, define regulatory requirements, and conduct risk assessments as necessary
  • Act as the point of contact for ex-US/ex
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