This position is overall accountable and responsible for project managing compilation and publishing of global submissions, as well as supporting the overview of all submissions to ensure deliverables across a given portfolio.
As a Submission Manager in Global Regulatory Affairs at LEO Pharma A/S, your responsibilities include:
- Act as Project Manager of tasks related to compilation and publishing of simple 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
- Support to Submission Manager lead of Global Regulatory Team – Giving input to overview/status of submission activities under the guidance of senior colleagues as required.
- Support 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
- Responsible for handling deviations relating to documentation practices within the scope of GRA
- Providing feedback/new ideas for improving the submission process and taking part in specific improvement activities.
- Additional duties as assigned by LEO Pharma Management.
- Complete all company-based and job-related training as assigned by LEO Pharma within the required timeline.
