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Katrin Rupalla, PhD, MBA
Regulatory Affairs Lead

Katrin Ym.JPG
  • LinkedIn

  • Over 25 years in Regulatory Affairs in Oncology and CNS in industry

  • Former SVP Regulatory Strategy, Quality & Medical Documentation @ Lundbeck

  • Industry experience with Roche, Celgene, Bristol-Myers Squibb and Lundbeck

  • 6 years of CNS  academic research experience

Specialties

  • Regulatory Strategy (global, i.e. US, EU, CN)

  • World wide Health Authorities meetings

Experience

  • Regulatory Strategy – Implementation of world-wide regulatory strategy for multiple early and late phase compounds and type of product classes in oncology, HIV, diabetes, CNS and immunology etc.

  • Regulatory Submission & approval management – Supervised or directly led world wide approvals of multiple new compounds and indications for products with main focus on oncology, HIV and CNS area.

  • Strategic planning and conducting of more than 200 HA meetings with EU agencies, FDA, NMPA, Health Canada, PMDA, CDE and emerging market Health Authorities

  • Conducted multiple regulatory due diligence assessment for early and late stage projects and company integration after acquisition

  • In depth knowledge of Chinese regulatory framework and R&D strategies through direct working experience in China.   

  • Companion diagnostic development strategy and device regulatory framework in US and EU – Oversaw multiple projects integrating device development with medicinal product development incl. companion diagnostics, administration devices etc.

  • Regulatory issue management for GCP, GMP, safety issues etc – handled multiple major development issues incl. strategy for scientific and data analysis, risk mitigation and communication with HAs (e.g. clinical hold, Article 20, MTD determination, GCP breaches, emerging safety issues etc.).

  • In depth management experience as senior leader of large and small RA teams – Experience with establishing RA organization in small biotech companies to management of large RA teams of up to 200 employees. In depth understanding of RA organizational design and change management.

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