Hildegard joined NDA in January 2009. Specializes in European regulatory procedures including linguistic reviews and lifecycle activities, regulatory project management as well as regulatory planning and QC management. Also leads activities for several non-European countries.
Key Areas Of Expertise
- Regulatory strategy advice and project management for strategic and operational projects within Europe as well as several non-European countries
- Preparation / Coordination of Scientific Advice and Pre-Submission Meetings with the EMA and National European Health Authorities
- Preparation / Coordination of PIP applications with the EMA
- Regulatory project management and compilation of new marketing authorization applications (CP, national, MRP, DCP) including Linguistic Review Procedures
- Maintenance of marketing authorization (e.g. variations, extensions, renewals, updates of regulatory part of PSUR) (CP, national, MRP, DCP)
- Marketing authorization transfers
- Development of product information documentation
- Review of promotional material in compliance with approved product information
- System and controlled quality document development in Regulatory Affairs
- Team Leader, including a supervisory function for Regulatory Affairs, where clients have outsourced all activities to NDA
Hildegard is a Certified Pharmaceutical Technician she spent 6 years in public pharmacies, then joined the pharmaceutical industry in 1996 and worked in Regulatory Affairs and Quality Assurance. She began her career in Regulatory Affairs and Quality Assurance at a Generics company, followed by several years in Regulatory Affairs at the European Headquarter of a global pharmaceutical company and one year at a CRO.