Regulatory Submission Management Professional
Applications are invited for the permanent position of a Regulatory Submission Management Professional within the Regulatory Submission Management Department in Dublin.
As a Submission Manager your overall objective is to plan, manage and facilitate the delivery of submissions within a given product/portfolio. This position is the 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 keep an overview of the Regulatory Submission Pipeline for life-cycle submission activities. This includes liaising across regulatory content owners inside and outside RA and our sourcing partner
- Plan, prepare, and drive the submission strategies
- Take active part of the regulatory cross-functional focus team within a portfolio representing Submission Management and acting as counterpart to other parts of Regulatory Affairs (RA) working within the same portfolio (e.g. RA CMC, RA Labelling and Regulatory Affairs Project)
- Monitor progress performance on the Regulatory Submission Plans and communicate goals, status, challenges, opportunities, risks as well as potential solutions to relevant stakeholders
- Authoring and reviewing Module 1 documentation
- Coordinating the review of published output
- Coordinating responses to health authority questions and commitments
- In close collaboration with sourcing partner, ensuring that LEO Pharma’s regulatory information management system is updated with submissions details, and that documents are uploaded in the 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 project managing regulatory activities/submission pipelines
- Project manager skills required (communication, collaboration and presentation skills as well as Planning and delegation skills; strong ability to manage a submission pipeline, keep the overview and prioritise; strong drive and ability to execute according to 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.
LEO PHARMA IS AN EQUAL OPPORTUNITIES EMPLOYER