Regulatory Submission Management Professional

On behalf of our client, we are currently recruiting for a Regulatory Submission Management Professional.

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.

Key Responsibilities:

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 companys 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 companys 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.

If you are interested in applying for this role please call Linda on +353 1 2784671 or email Ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment.