Job ad: Regulatory Senior Scientist

Regulatory Senior Scientist

We are looking for a Regulatory Senior Scientist to fill a vacant position in Dossier Management, a department within the Regulatory Affairs Division. Regulatory Dossier Management employs 16 highly skilled and committed colleagues involved in regulatory activities from early to late stage development projects and marketed products. Regulatory Dossier Management is also responsible for regulatory activities for clinical trials.

Your job and key responsibilities:

• Leading execution of global regulatory strategies for Lundbeck development projects and products, hereunder submission of initial marketing authorisation applications as well as handling requests from the Competent Authorities during the assessment of the dossier
• Providing regulatory guidance taking into consideration local regulatory requirements