Regulatory Affairs Specialist

About the Company

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. We bring preclinical and clinical development, manufacturing of clinical batches and regulatory filings together in-house. As a Regulatory Affairs Specialist, you will work directly with the scientists and manufacturing colleagues whose data you use to write clinical trial dossiers.

Key Accountabilities and Responsibilities

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.

Desired Skills and Experience

Your CV and motivation letter should show that you have:

• A Master’s or preferably PhD degree in life sciences, chemistry or a related discipline;
• At least five years of relevant experience in Regulatory Affairs, preferably in early clinical development;
• Experience with ADCs. We also welcome small-molecule experience combined with exposure to biologics during your studies or career.
• Hands-on experience writing CMC and nonclinical sections of clinical trial dossiers and familiarity with the EU Clinical Trials Regulation. CTIS training or experience is helpful. Experience with CTA submissions in other regions is a strong advantage;
• Strong organizational skills, with the ability to prioritize effectively, coordinate multiple activities and deliver high-quality work within challenging timelines;
• The ability to maintain a broad overview while also paying close attention to detail;
• A proactive, pragmatic, and hands-on approach, with the curiosity to learn new topics and the ability to work independently and take ownership of deliverables;
• The ability to work effectively in multidisciplinary teams and communicate clearly with internal and external stakeholders;
• Strong written and verbal communication skills, with the ability to explain regulatory topics clearly and translate regulatory requirements into practical recommendations;
• Proficiency in Microsoft Office and ability to learn new digital tools and systems.

Why Join Byondis?

On our Nijmegen campus, you’ll work directly with the scientists and manufacturing colleagues developing new cancer medicines. Having research, development and clinical manufacturing on one site means you can discuss the data with the people who generated them and see how your dossier supports a medicine’s move into clinical trials. You’ll take responsibility for the regulatory work on your own project and work closely with the Head of Regulatory Affairs. In a small team, you’ll have room to ask questions, contribute ideas and broaden your experience across the quality, nonclinical and clinical aspects of drug development.

Compensation

• Byondis offers a competitive salary, an excellent pension scheme
• 30 days of annual leave for full-time employees and company events throughout the year.
• Contract hours: 32-40 hours per week
• Salary: based on experience
• Location: Nijmegen, with the option to partly work remotely

Applicants must be EU nationals or hold a valid permit to work in the European Union. Applications from Recruitment Agencies will not be accepted.