About me

My name is Dr. Iris Bresink, and I am a medical and regulatory writer with over 25 years of experience in clinical research and regulatory affairs. Throughout my career, I have had the privilege of collaborating with leading pharmaceutical companies, contributing to the successful approval of several major drugs across a variety of therapeutic areas.

My expertise includes developing and authoring a wide range of regulatory and clinical documents, such as New Drug Applications (NDAs), Biologic License Applications (BLAs), Marketing Authorization Applications (MAAs), and Investigational New Drug Applications (INDs). I strive to provide clear, accurate, and impactful writing to support your regulatory submissions and ensure a smooth approval process.

My goal is to simplify complex scientific concepts and ensure your work meets regulatory requirements for success.

Contact me

Therapeutic Areas of Expertise

  • Women’s Health
  • Hematology
  • Oncology
  • Men’s Health
  • Respiratory Conditions
  • Gastroenterology
  • Rare Diseases
  • Dermatology
  • Immunology
  • Gene Therapy
  • Pain Management

Professional Milestones

This overview highlights key stages of my career. For my full CV, please contact me.

Since November 2024
Managing Director — Bresink Pharmaceutical Services GmbH

Development and authorship of key regulatory submission documents including clinical study protocols and reports, clinical overviews and summaries (CTD Modules 2.5 and 2.7), briefing books, investigator’s brochures, and regulatory responses across multiple therapeutic areas.
Workshop Leader at European Medical Writers Association (since 2025).
Germany

2010-2024
Medical Writing Strategist / Medical and Regulatory Writer

Led submission strategies for NDAs, BLAs, and MAAs of new molecular entities and life-cycle management of approved products. Authored clinical overviews and summaries, briefing books, PIPs, clinical study reports, and post-approval documents. Established a lean medical writing approach and provided cross-functional document support.
Bayer AG Wuppertal, Germany

2002 – 2010
Medical and Regulatory Writer

Responsible for clinical CTD strategy, authoring clinical overviews and summaries, briefing books, and responses to Health Authorities for new molecular entities and life-cycle management (FDA, EMA, worldwide).
Schering AG, Berlin, Germany

1998-2002
Dossier Manager & Head of Drug Regulatory Affairs

Managed mutual recognition procedures in gastroenterology and prepared and submitted post-registration documentation for affected products.
ASCHE AG, Hamburg, Germany

1995-1997
Postdoctoral Researcher in Neuroscience

University of Bristol, Medical School, Bristol, UK,  and Schering AG, Berlin, Germany

1995
Doctoral Thesis (Dr. phil. nat.) in Natural Sciences (Neurodegeneration)

Institute of Pharmacology, University of Frankfurt/Main, Germany

1992
License to Practice Pharmacy (“Approbation als Apothekerin”)

University of Frankfurt/Main, Germany