Copenhagen, Capital Region of Denmark, Denmark
Well time menaged, organized, task oriented and focus on achiving targeted goals; individual contributor capabel to fit in the team, always strive to excelence
Leading a dedicated regulatory CMC team focused on the lifecycle management of semaglutide. Responsible for navigating complex global requirements, securing post-market approvals, and spearheading development projects that sustain market leadership.
Leading department responsible for CMC activities for selected portfolio of antibodies
Heading department within Regulatory CMC area, responsible for development and LCM activities of biologics and ATMPs within rare disease areas.
New drug applications Renewals Life cycle management Medical Devices Registrations/Renewals Pharmacovigilance of medical products and medical devices Handling of Change Requests Handling of Non Conformities Handling of Document Control Process