Senior Manager Regulatory Affairs | Pharmacist (m/w/d)

Job Summary

Join CatalYm, a dynamic biotech company in Martinsried, as a Senior Manager Regulatory Affairs, playing a pivotal role in advancing innovative immune-oncology therapies. In this position, you will oversee global and regional regulatory aspects of multiple clinical trials, ensuring meticulous compliance with ICH-GCP guidelines, EU CTR, and other relevant regulations. Your day-to-day will involve developing and reviewing clinical trial documents, responding to Agency requests, and coordinating interactions with Health Authorities. You will also contribute to process improvements and SOP development, ensuring all assigned trials are inspection-ready. This role is ideal for a proactive professional with a strong background in regulatory affairs, excellent organizational skills, and a passion for bringing next-generation immuno-oncology products to patients.