Job Description:
As RA Senior Associate, you will be responsible for compiling and publishing the submission of Marketing Authorisation application (MAA)/Life cycle Management application) to European Health Authorities. The key responsibilities are:
Facilitation of submission planning meetings with RA colleagues from Product portfolio as well as Submission Management coordinator from RAHQ Denmark
Compilation of dossier based on TOCs provided by RA HQ in eCTD format
Publishing the dossier & perform post publishing activities
Add navigation elements like hyperlinks, Bookmarks
Perform validation of submission
Upload submission in EMA Gateway
You will be delivering high quality registration dossiers, which require a good understanding of Regulatory guidelines, Administrative, CMC, Non-Clinical & Clinical documentation, different registration file formats (Centralised procedure, Mutual Recognition procedure, Decentralised procedure & National Procedure for EU) and the Regulatory dossier publishing process. Hands on experience in publishing tools like Lorenz Docubridge, Liquent Insight, ISI Publishing, ISI Tool Box, Adobe Acrobat, etc. Hands on experience in validation tool like EURS, Lorenz, etc. Experience in xml editing & Document Management system is preferable. Exposure to e-submission gateways are mandatory.
The job involves close collaboration with Global Regulatory Teams in Denmark, as well as Novo Nordisk affiliates across the EU to ensure timely submissions. Excellent communication and English proficiency is a must, especially with the global perspective of the role.
Stakeholder satisfaction is one of the departmental and individual goals, so service mindedness towards our stakeholders within Novo Nordisk is a key priority.
Our organisation is dynamic, with change management being an essential part of our everyday life. In addition, there is a constant focus on optimizing our working processes, and you will be involved in cross functional improvement activities.
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