Director Global Regulatory Affairs (Oncology) | Pharmacist (m/w/d)

Job Summary

This senior role seeks a Global Regulatory Lead to define and execute comprehensive Regulatory Strategies for assigned development projects, focusing on oncology therapeutics. Day-to-day responsibilities include acting as the primary regulatory lead, defining the strategy for and conducting interactions with major health authorities (e.g., EMA, FDA, PEI), and developing the core regulatory storyline for applications and dossiers up to marketing authorization. The Director will coordinate the preparation and review of critical regulatory documents (e.g., IBs, BLA/MAA), contribute to process optimization within Global Regulatory Affairs (GRA), and supervise regulatory vendors. The ideal candidate must possess a university degree in natural sciences and at least nine years of relevant Regulatory Affairs experience, coupled with business fluent English, to navigate the complex global regulatory landscape in cancer therapy development.