Submission Manager – Global Regulatory Affairs
On behalf of my client, I am recruiting for a Submission Manager – Global Reg Affairs on a 12-month maternity contract.
The successful candidate will maintain the overview of all submissions, along with being accountable and responsible for project managing compilation and publishing of global submissions. This role will directly report to the Head of Regulatory Submission Management and does not have any direct reports.
· Act as Project Manager of tasks related to compilation and publishing of global Regulatory submission, and create and manage cross-functional timelines for global submissions.
· Leading a global (external) publishing team in the context of a given submission.
· Responsible for technical interactions with global HA, i.e. gateways, validation issues and similar.
· Submission Manager lead of Global Regulatory Team - Providing overview/status of submission activities relevant to the team and presenting and highlighting the dossier strategy and relevant submission intelligence/approach, risks and solutions as relevant, under the guidance of senior colleagues as required.
· Standardizing best practices for management of regulatory submissions to ensure consistency (e.g. defining submission process and timelines, adopting global core dossier and abbreviated dossiers concept and principles)
· Responsible for ensuring processes related to eCTD readiness and authoring submission documentation are adhered to (in close collaboration with Regulatory System and Data Management Dept)
· Responsible for intelligence related to eCTD readiness and GxP, Good Documentation practices.
· Responsible for end user liaison and advocacy within and outside of GRA, as required for document management.
· BA/BSc Degree in scientific discipline required; Master’s Degree preferred
· Experience in both US and global submissions beneficial with 5+ years’ experience working in Pharma/Biotech Regulatory Affairs and within different areas (CMC, Labelling, Clinical, Submission Management, Local RA)
· 3+ years’ experience working within a Submission Management function, managing global submissions with knowledge of global regulatory requirements for major markets US, EU, JP, CN, CA and RoW
· Understanding of CMC, Labelling, Clinical within pre-approval and/or post-approval activities
· Solid knowledge and experience within Submission Management and the different market/HA requirements in relation to dossier management and submission processes
· Solid project management, communication and presentation skills as well as good ability to plan, manage a submission pipeline and manage compilation and publishing of global submissions; ability to keep the overview and prioritize; strong drive and ability to execute according to plan, create and manage cross functional timelines and collaborate with relevant stakeholders
· Time and quality focused when executing on submissions; focused on KPIs and deadline driven
If you are interested in applying for this role, please call Ciara on +353 1 2784671 or email firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com