A vacancy exists for a temporary (12 month maternity leave cover) Submission Manager (P4) within the Regulatory Affairs Submission Management Department based in LEO Pharma Dublin. This role will directly report to the Head of Regulatory Submission Management.

You will join a team of dedicated and skilled submission mangers responsible for ensuring compliant and timely global submissions across all portfolios. We are based in Ballerup, Denmark, in Dublin, Ireland and in Madison, NJ USA.

Your role will be, as a key member of the team, accountable and responsible for project managing compilation and publishing of global submissions, as well as maintaining the overview of all submissions to ensure deliverables across a given portfolios. This role does not have any direct reports.

The primary tasks of the role include (but are not limited to):

• Act as Project Manager of tasks related to compilation and publishing of global Regulatory submission

• Creating and managing cross-functional timelines for global submissions with consideration of key interdependencies

• Leading a global (external) publishing team in the context of a given submission

• Managing the timely delivery of compliant global submissions

• 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

• In addition, you will continuously provide feedback and new ideas on improving the submission process and take part in improvement activities. Some travel may be required.

• BA/BSc Degree in scientific discipline required; Master’s Degree preferred

• Experience in both US and global submissions beneficial

• 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

• Knowledge and experience interacting with different people (e.g. Local RA, publishing team etc.) also with the understanding of cultural differences and perspectives

• The ability and willingness to travel internationally (mainly Europe) approximately 10-15%

• Must be able to perform all essential functions of the position, with or without reasonable accommodation