Regulatory Affairs Specialist

Byondis is an independent, fully integrated biopharmaceutical company in Nijmegen, the Netherlands. We are engineering antibody-drug conjugates (ADCs) to tackle cancer and other difficult to treat diseases. Our teams combine expertise in disease biology, linker-drug technology and antibody-drug conjugation to design targeted cancer medicines. Our Nijmegen campus brings together preclinical and clinical development, in-house GMP manufacturing capabilities and regulatory affairs. As a Regulatory Affairs Specialist, you will work directly with the scientists and manufacturing colleagues whose data you use to write clinical trial dossiers.

As Regulatory Affairs Specialist, you will join a small and dedicated RA team supporting early development and clinical-stage programs. The team interprets regulatory requirements, prepares and maintains submission documentation, and coordinates Clinical Trial Applications (CTAs) across different regions.

Your work will cover CMC, nonclinical and clinical topics for both biological products and small molecules. You will work in multidisciplinary project teams and interact with colleagues across the company, regulatory authorities and CROs. Your responsibilities include compiling and maintaining regulatory documentation, such as IMPDs, IBs, DMF/ASMF and API documentation, and supporting scientific advice activities. You will coordinate the timely availability of documents for CTA submissions and responses to questions from authorities. You will also keep up to date with relevant regulatory requirements and advise project teams on how to apply them.