Job Description

Your mission

• Oversee regulatory aspects of several clinical trials on a global/regional level in the field of immune-oncology therapies. Ensure consistent, high-quality execution across studies and vendors within regulatory requirements.
• Oversee the development and review of clinical trial documents, and responses to Agency requests in alignment with regulatory and ethical standards and the development of portfolio documents.
• Ensure compliance of assigned clinical studies with regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e., policies, SOPs, instructions).
• Collaborate with internal and external cross-functional teams for assigned clinical trials as representative for Regulatory Affairs
• Set-up and coordination of Health Authority interactions as applicable
• Contribute to process improvement and SOP development.
• Ensure accurate trial documentation and inspection readiness of assigned trials, participate in internal audits and HA inspections, and HA meetings as required.
  
  

• Bachelor’s or master’s degree in life sciences with minimum of 4 years of experience in a Regulatory Affairs role within Biotech, Pharma or CRO organization; experience with oncology studies is a plus.
• Excellent knowledge and understanding of clinical trial processes, methodology and regulations (ICH-GCP, and any local regulations). Experience with EU CTR is a plus.
• Excellent organizational and planning skills; able to effectively manage multiple competing priorities, identify and solve conflicts (critical thinking and risk analysis), meet deadlines without direction.
• Good negotiator and communicator, strong interpersonal and analytical skills.
• Proficient computer skills (excellent knowledge level of MS Excel and MS PowerPoint) and fluent in English with excellent oral and written skills; good level of German.
  
  

• Creative working in X-functional teams
• Short communication channels
• Dynamic and goal-orientated environment
• Open and appreciative corporate culture in a multicultural environment
• Limited domestic and international travel required, when necessary
• 2 days home office per week

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