✨ The Role in One Sentence

CatalYm is seeking a Manager of Regulatory Affairs to oversee regulatory aspects of clinical trials in immune-oncology, ensuring compliance and quality execution.

📋 What You'll Likely Do

• 30%: Oversee regulatory aspects of clinical trials on a global/regional level.

• 30%: Develop and review clinical trial documents and responses to Agency requests.

• 40%: Ensure compliance with regulatory requirements, ICH-GCP guidelines, and SOPs.

🧑‍💻 Profiles Doing This Job

• High Priority: Bachelor's or Master's degree in life sciences.

• High Priority: 4+ years of experience in Regulatory Affairs within Biotech, Pharma, or CRO.

• High Priority: Excellent knowledge of clinical trial processes and regulations (ICH-GCP).

📈 How This Role Will Look on Your CV

• Managed regulatory affairs for global clinical trials in immune-oncology.