Marianne Toft Email and Phone Number

Responsible for the global RA function, which comprises of four departments:- Regulatory Business Projects and Support- Regulatory System Support and Data Management- Regulatory Processes and Compliance- Regulatory Submission ManagementLeader of 4 direct reports and app 50 employees based in Ballerup, Dublin and Madison and MiamiFocus areas:- Global Leadership- Organizational development and strategic changes- Project Management- Vendor Management- Communication and Business Change Management- Quality Management- Regulatory IT modernisation and Data Management- Regulatory Operations and Support

Responsible for the global RA function, which comprises of four departments:- Regulatory Business Projects- Regulatory System Support- Regulatory Processes and Compliance- Regulatory Business ServicesLeader of 4 direct reports and 25 employees based in Ballerup and MiamiFocus areas:- Global Leadership- Organizational development and strategic changes- Project Management- Regulatory Operations and Support

Responsible for the global RA function, which comprises of following departments:- Regulatory Strategy- Regulatory Labelling and AdPromo- Regulatory CMC- Regulatory EU+- Regulatory Internattional- Regulatory Business SupportFocus areas:- Global Leadership- Organisational management

Strategic business and organisational projects in Global Regulatory Affairs and/or cross-functional support to the VP of GRA in managerial and leadership tasksFocus areas:- Organizational strategy and roadmap development

Educational leave:Graduated as Master of Anthropology of Health, Copenhagen UniversityStudying Anthropology of Health, Copenhagen University- Anthropological fieldwork in Ghana- Writing dissertation: How quality of medicines is perceived and negotiated by pharmacy staff and users in GhanaCertification in Project Management - PRINCE 2 Foundation and PractitionerGatekeeper and external examiner for Module 2: EU Applications for Marketing Authorisations, Paediatric Investigation Plans, Clinical Trials and Orphan Drug Designation, Medicademy Regulatory Affairs

Responsible for the global RA function, which comprises of four departments:- Global Submission Management and Operations- Business System Project Management- Buseinss System Support- Regulatory Operations in JapanLeader of 4 direct reports and 73 employees based in Boston, Chicago, London and OsakaResponsible for the close down of Global Regulatory Affairs in RoskildeFocus areas:- Global Leadership- Organizational development and strategic changes- Project Management- Regulatory Operations and Support

Responsible for the global RA function, which comprises of following departments:- Electronic document management and submissions- Global Regulatory tracking- Record Management- Global Regulatory Affairs Communication- Global Regulatory Affairs Compliance and Quality Management- Strategic SupportLeader of 7 direct reports and 40 employees based in Chicago, London and RoskildeSite head for Global Regulatory Affairs in Roskilde Focus areas:- Global Leadership- Organizational development and strategic changes- Project Management- Communication and Business Change Management- Quality Management- Regulatory Operations and Support

Responsible for the Global RA function, which comprises of following departments:- Electronic document management- Regulatory tracking- Submission management- Regulatory Affairs Communication and Business Change Management- Regulatory Affairs Quality Management and Compliance- Strategic SupportLeader of 6 direct reports and 19 employees based in Konstanz and RoskildeFocus areas:- Global Leadership- Organizational development- Project Management- Communication and Business Change Management- Quality Management- Regulatory Operations and Support

Management of the Regulatory Operation function in Nycomed with 8 employees based in Roskilde

Regulatory Affairs activities for products and registrations

Regulatory Affairs activities of products and registrations

Regulatory maintenance of products manufactured by the Danish Hospital Pharmacies.