About us
CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!
(Senior) Manager Regulatory Affairs (f/m/d)
Festanstellung, Vollzeit · Planegg-Martinsried
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