Associate Submission Manager – Global Regulatory Affairs at LEO Pharma A/S

If you would like to work with a dedicated team of submission managers on global submissions, this is a great opportunity.
In Submission Management we are looking for an associate submission manager to help manage and facilitate global regulatory submissions to ensure deliverables for a given portfolio. 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.
The job
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 portfolios.
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

In addition, you will continuously provide feedback and new ideas on improving the submission process and take part in improvement activities. You will be based at our office in Ballerup, Denmark. Some travel may be required.

Your qualifications

  • BA/BSc Degree in scientific discipline required; Master’s Degree preferred
  • Strong command of the English language is essential
  • Previous experience working in global regulatory affairs is not a requirement but an intertest in the area is essential and some knowledge would be beneficial.
  • Awareness of pre-approval and post-approval activities
  • Awareness of global HA requirements in relation to dossier management and submission processes

You will have an interest in project management, with strong communication and presentation skills as well as good ability to plan and prioritize; with strong drive and ability to execute according to plan. You will be able to collaborate with a large number of stakeholders with an understanding of or interest in, cultural differences and perspectives.
Contact and application
If you have questions, please do not hesitate to contact Sinead Whelehan, Senior Manager, Submission Management, Global Regulatory Affairs, at or +353 87 4175211.
Please apply via the link at our website and remember to attach application and CV. The deadline is 18th April 2021.

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Ballerup, Greater Copenhagen, DK


Sinead Whelehan

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