Regulatory Submission Management Professional
Applicants are invited to apply for the temporary position of a Regulatory Submission Management Professional within the Regulatory Submission Management Department in Dublin. The temporary position is for 36 months. This position is not considered a manager position and successful candidates will not have any direct line reports.
As a Submission Manager your overall objective is to plan, manage and facilitate the delivery of submissions within a given product/portfolio. In this position you will be overall accountable and responsible for project managing individual submissions under an asset, from planning through to case closure. This position involves close collaboration with LEO Pharma’s global submission sourcing partner.
Your priority tasks will be:
- Manage and have an overview of the Regulatory Submission Pipeline for all life-cycle activities. This includes liaising with regulatory content owners inside and outside Regulatory Affairs (RA) as well as our sourcing partner;
- Plan, prepare, and drive submission strategies;
- Take an active part and represent Submission Management in our cross-functional regulatory focus teams and act as a counterpart to other parts of RA, working within the same portfolio (e.g. RA CMC, RA Labelling and Regulatory Affairs Projects);
- Monitor progress performance for regulatory submission plans and communicate goals, status, challenges, opportunities, risks as well as potential solutions to relevant stakeholders;
- Author and review Module 1 documentation;
- Coordinate review of published output;
- Coordinate responses to health authority questions and commitments;
- In close collaboration with sourcing partner, ensure that LEO Pharma’s regulatory information management system is updated with submission details, and that documents are uploaded to our document management system according to compliance and quality standards.
Experience & Qualifications
- Scientific Master degree, bachelor degree or similar work experience;
- 3 years or more experience working in Regulatory Affairs within different areas (CMC, Labelling, Clinical, Submission Management, Local RA or similar);
- Knowledge and preferably experience within Submission Management in relation to submission processes;
- Understanding of CMC and Labelling components for post-approval activities;
- Solid project manager skills and experience from managing regulatory activities/submission pipelines;
- Skills required: communication, collaboration, presentation skills as well as Planning and delegation skills; strong ability to manage a submission pipeline, keep an overview and prioritise; strong drive and ability to execute according to a plan.
Furthermore, you are:
A strong communicator, passionate and enthusiastic in your way of working, a professional with positive and proactive influencing skills with the ability to take ownership, a strong and proactive team player who thrives on working in an international environment, a professional who can motivate others to adapt to new processes and understand how to build efficient working relationships with both internal and external stakeholders.
Application, including C.V. should be submitted before 12/07/19
All internal candidates must notify their direct manager if they apply for this role. Failure to do so, will result in you not being considered for this position.
LEO PHARMA IS AN EQUAL OPPORTUNITIES EMPLOYER