A vacancy exists for a Temporary (12 month- maternity leave) Senior Submission Manager (P5) within the Regulatory Affairs Submission Management Department based in LEO Pharma Dublin. This role will directly report to the Head of Regulatory Submission Management.  

Your role will help us set the direction for the department going forward, manage and facilitate complex regulatory submissions and also mentor and train less experienced colleagues, to ensure deliverables across many portfolios.. 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.

• BA/BSc Degree in scientific discipline required; Master’s Degree preferred  
• 8+ years’ experience working in Pharma/Biotech Regulatory Affairs and within different areas (CMC, Labelling, Clinical, Submission Management, Local RA) 
• 5+ years’ experience working within a Submission Management function, managing complex global submissions with in-depth knowledge of global regulatory requirements for major markets US, EU, JP, CN, CA and RoW 
• Strong command of the English language is essential 
• Solid understanding of CMC, Labelling, Clinical within pre-approval and/or post-approval activities 
• Solid knowledge and experience within Submission Management and global market/HA requirements in relation to dossier management and submission processes 
• The ability and willingness to travel internationally (mainly Europe) approximately 10-15%