Paulina Jordan

Regional Regulatory Lead for development projects and marketed products in the area of GLP-1 Diabetes, Obesity and Alzheimer's disease

• Assessment of EU project plans and documents intended for submission to regulatory authorities • Monitoring and evaluation of regulatory developments at national and European level • Regulatory responsible for product launches in Germany • Affiliate representative in project groups for process improvement on national and global level

• Mangagement of regulatory activities for Marketing Authorisation Applications, Renewals and Variations of drugs (NP, MRP, DCP, CP) and medical devices on the German market • Translation and maintenance of German SmPC, labelling, patient leaflets and medical device instructions for use

• Maintenance of local Abbreviated Prescribing Info and drug product listings in pharmaceutical directories • Coordination of SmPC updates with Sales, Marketing and Product Supply departments • Preparation of yearly PQR report

Research associate in the group Bioprocess Engineering • Contract research in cooperation with BASF • Metabolic engineering, strain development, GC-MS, LC-MS/MS analytics

Research at the Institute for Molecular Biosciences in the field of biotechnology with yeast (Plasmid construction, protein purification, fermentations)

Internship in the department of Molecular Virology (cell culture of human liver cells, immune fluorescence microscopy, ELISA, Western Blot)

ICH-GCP Guideline, AMG / MPG, Klinische Studien von Arzneimitteln und Medizinprodukten, Pharmakologie und Medizin

Mikrobiologie, pharmazeutische und industrielle Biotechnologie, Bioanalytik

Molekularbiologie, Biochemie