Director Regulatory Affairs

Permanent position

Start as soon as possible

32–40 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 manufacturing

Your 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 required

We 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