Birger Kintzel

Drug Regulatory Affairs services, such as

• Interim management
• Contracting (home based or at client’s site)
• Preparing and submitting CTAs and MAAs
• RA lead function in development projects
• Preparing Regulatory strategy documents
• CMC dossier support and project transfer
• Scientific Advice meetings incl. follow-up
• RA Life-cycle work (variations, renewals, etc.)
• Interface with BfArM, PEI, local authorities of supervision
• Contact point to Rote Liste GmbH, Fachinfo-Service, ABDATA
• Labelling (SmPC, Patient Leaflet, CCDS etc.)
• RA in-house training to company staff
• Due diligence meetings
• Review of Ad/Prom documents

Industry positions held (1993-2008):

• RA Manager at Janssen-Cilag GmbH
• Head of RA at Synthelabo Arzneimittel GmbH
• Head of RA at Pharmacia GmbH
• Senior Director EU RA at Elan Pharma Ltd
• Global RA Director at Baxter Healthcare

Freelance RA consultant since 2008
Independent Consultant at Parexel International since 2014
Regulatory Affairs Director at Cytolon AG since 2015

Diplom-Pharmazeut (PharmD)
Apotheker Approbation (Board certified pharmacist)
Dr.rer.nat. (PhD)

Education:

Studies of pharmacy at Ernst-Moritz-Arndt university of Greifswald (Germany)

Experience:

22 years experience in Regulatory Affairs (for details kindly refer to www.kintzel-regulatory.com)

Areas of Expertise:

Regulatory Affairs