Senior Regulatory Affairs Clinical Specialist

Job description

Does it excite you to work with regulatory strategy in clinical development, and do you have experience with global submissions and health authority interactions? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague. Your new position: As a Senior Regulatory Affairs Clinical Specialist, you will provide regulatory input and direction across clinical development programs. Partnering closely with cross-functional teams, you will help navigate evolving regulatory requirements and enable timely, high-quality submissions. This role combines strategic thinking with hands-on execution to support development plans that bring innovative peptide-based medicines to patients. We offer exciting responsibilities: - Provide regulatory expertise and guidance in global development projects - Act as regulatory lead in clinical trial teams across planning, execution and reporting - Contribute to EU MAA and US NDA documentation and submissions - Support health authority interactions and Q&A strategies - Collaborate cross-functionally with regulatory, clinical, non-clinical, and writing teams - Monitor new legislation, guidelines, a...