The Role: The Global CTA Submission Manager is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs. They...
The Role: The Global CTA Submission Manager is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs. They may operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.
- Drives global submission management activities for their assigned assets. Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverable associated with CTA submission development and execution for designated assets and/or geographies.
- Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
- Liaises with Study Management, regarding essential core documents that cross both HA and EC submission and translation processes
- Prepare, review and submit submissions to HA/Regional CTA , in order to obtain all necessary authorisations /approvals pertaining to the clinical trial conduct.
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required
- Guide and leads CTA submissions and process improvement projects, making decisions independently
- University level (Life Sciences background is preferred)
- In-depth understanding and proven execution of CTA processes globally
- Hands on experience within Clinical Regulatory affairs.
- Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive
- Understanding of EU Clinical Trial Regulation Desirable
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.