Dr. Barbara GollobSenior Regulatory Expert Labeling and Combination Products

Barbara has more than 13 years of global pharma labeling experience.

She has a strong focus on biosimilars and combination products, profound regulatory labeling experience in development and maintenance of complex generics, biosimilars and drug/device combination.

Barbara has a sound medical background in academic research and teaching experience in EU and South America. She is a successful leader of labeling teams for the development of combination products for the EU, US, CA, AU, NZ, JP and in ROW markets.

She also focuses on regulatory labeling and successful negotiation and direct interaction with health authorities in HRM and ROW as well on process and workflow optimization.

She is experienced in efficient people and project management and fluent in German, English and Spanish.

Expertise:

  • Anti-virals (HSV, CMV, HIV)
  • Antibiotics
  • Bronchodilators/Respiratory (Asthma/COPD)
  • CNS/Neurology (Parkinson)
  • Gene therapy