This role will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team, they will achieve the...
The Role:The Global CTA Submission Manager is accountable for working with contributing business lines to lead operational submissions execution for designated CTAs. To operate as regulatory operational Subject Matter Expert for a CTA and drive submission teams towards the timely delivery of globally compliant submission-ready components.
- To drive global submission management activities for assigned assets. Partner with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables 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
- Liaise 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 Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
- Responsible for the co-ordination of translations for core documents required for submission
- Manage the compilation for core package build, contributing to CTA and authoring documentation as required
- Act as Subject Matter Expert for Regulatory Operations and provides country-level intelligence on clinical trial regulatory. Ensure that local country regulatory intelligence, as it pertains to the activities of the CTR team, is maintained on the central repository, e.g., Competent Authority submission requirements
- Escalate, inform, and resolve any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
- B.S. /B.Sc. is in Pharmacy or any Life Sciences
- Strong working knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management.
- In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
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.