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Use innovative regulatory approaches and provide strategic regulatory guidance for assigned projects/products. Develop and implement regulatory strategies, integrating inputs from regulatory team and cross functional partners to build globally aligned
You will lead the development and execution of global regulatory strategies in close collaboration with co-development partners and internal and external stakeholders. Acting as regulatory lead for complex projects, you will draw upon
Ensuring the timely generation of a wide range of clinical regulatory documents required for the development of novel therapeutic agents from discovery up until and beyond marketing approval. This includes providing hands-on scientific/medical writing
Provide clearly defined Quality expectations and a Quality strategy for the assigned program(s) within the BioNTech product portfolio; Critically evaluate new products and processes with respect to Quality and compliance requirements. Work with
Develop Manufacturing Industrial Strategic Supply Plans for Drug Products throughout their lifecycle, aligned with the broader supply-network strategy; Build and oversee the strategic industrial project portfolio covering launches, lifecycle management,