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In this role, you’ll lead multiple projects, guide teams, and stay hands-on with PK and PK/PD analyses using tools like NONMEM and R. You’ll bring your regulatory know-how, storytelling skills, and passion for mentorship to help drive smarter, faster
You will be responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a specific focus on our key biologic (Nemolizumab). This involves signal detection, risk management
In the absence of the QPPV and, as delegated, to take on the role and responsibilities of the QPPV, incl. acting as a single PV contact point for the competent authorities in the EEA and the UK on a 24‑hour basis; Support the QPPV in the compliant
You will play a crucial role in driving the design, safety monitoring, and data analysis of the Company’s late-phase clinical trials studying TransCon C-type natriuretic peptide (CNP). This is an exciting opportunity to work in a fast-paced environment,
Responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsible for preparing and managing CMC regulatory