Education and Qualifications
| 2006 | Pharmacist specialised in Drug Information: Bavarian Professional body for pharmacists, Munich, Germany |
| 2003 – 2005 | Master in Drug Regulatory Affairs: Rheinische Friedrich Wilhelms University, Bonn, Germany |
| 1998 – 2001 | Dr. phil. nat., Pharmacology: Johann Wolfgang Goethe University, Frankfurt, Germany |
| 1997 | Licence to practice pharmacy |
| 1991 – 1996 | Pharmacy studies in Greifswald and Belfast |
- German: fluent
- English: fluent
- Russian: basic
- Spanish: basic
- French: basic
Employment History
| Jan 2022 to date | Head of CMC at Granzer Regulatory Consulting & Services GmbH, Munich, Germany |
| Jul 2019 – Dec 2021 | Principal Consultant at Granzer Regulatory Consulting & Services GmbH, Munich, Germany |
| Jul 2007 – Jun 2019 | Senior Consultant at Granzer Regulatory Consulting & Services GmbH, Munich, Germany |
| May 2005 – Jun 2007 | Senior Manager European Regulatory Affairs / Deputy Drug Safety Officer / Head of Quality Control, GPC Biotech AG, Martinsried, Germany |
| Nov 2004 – May 2005 | Regulatory Affairs Manager, AstraZeneca GmbH, Wedel, Germany |
| Feb 2003 – Sep 2004 | Manager Regulatory Affairs & Nonclinics / Head of QA, SWITCH Biotech AG, Neuried, Germany |
| Jun 2001 – Jan 2003 | Project Leader Cheminformatics, SWITCH Biotech AG, Neuried, Germany |
| Jan 1999 – Nov 2000 | Freelance writer for nonclinical and clinical reports, EPA Euro Pharma GmbH, Kronberg |
| Mar 1998 – Dec 1999 | Dispensing pharmacist (at weekends and at night), various pharmacies in the Frankfurt region |
Other Professional Activities
Member of German Society for Regulatory Affairs (DGRA)
Experience
24 years working experience in the pharmaceutical industry and 20 years in Regulatory Affairs, additional experience in QA/QC, Drug Safety, Nonclinical Development and Medical Writing. Held various positions with both large and small pharmaceutical/biotechnological companies. Extensive experience with CTA/IND and MAA/NDA/BLA/DMF submissions in Europe and the US for the various indications and product groups such as Dermatology, Oncology, and Antivirals; small molecules, vaccines, recombinant products including Biosimilars as well as cell- and gene therapy products such as CAR-T cell products, mRNA therapies and viral vectors.
In depth knowledge and involvement in European and US regulatory procedures. Authority interactions in Europe and the US including preparation of briefing materials, moderation of meetings. Preparation of clinical trial applications (CTAs, INDs). Global regulatory strategy including preparation of clinical and CMC development plans.
Many years of hands-on experience in the field of Regulatory CMC including review and authoring of IMPDs/INDs, DMFs and MAAs/NDAs/BLAs; involvement in Due Diligence activities; preparation of gap analyses; addressing technical questions and troubleshooting, complete CMC development support.