Permanent positionStart as soon as possible32–40 hours per week (part-time/full-time)Your Responsibilities:• As Director Regulatory Affairs, you will be responsible for the strategic direction, leadership, and coordination of all regulatory activities related to the marketing authorization of RESPILIQ• You will coordinate interactions with regulatory authorities such as BfArM, EMA, and FDA, and manage regulatory consultants and subcontractors working with O11 biomedical• You will provide regulatory expertise and support to key development areas, including: – Clinical development – Quality management / quality assurance (QM/QA) – GMP-compliant pharmaceutical manufacturingYour Profile:• You have at least 10 years of solid professional experience in the regulatory approval of new active substances (new chemical entities)• You are highly experienced in regulatory requirements and have a proven track record of working with (inter)national regulatory authorities• You demonstrate a structured, solution-oriented, hands-on working style, well suited to a professional start-up environment• You possess strong communication skills, are a team player, and have proven leadership capabilities in managing colleagues and external consultants• Very good written and spoken German and English skills are requiredWe Offer:• A responsible key position with significant scope for shaping and influencing outcomes within a highly professional start-up environment• Excellent working conditions in a motivated, interdisciplinary team• Attractive compensation package, permanent employment, and the opportunity to participate in the company’s success through our VSOP program• Workplace in the beautiful Vaalserquartier district of Aachen, easily accessible by car and public transport; in close proximity to the university hospital and the Netherlands.• Flexible working hours (32–40 hours/week) and the option of structured remote work