Advanced degree in a related field (MS, PhD, or MD, DVM) or MBA is preferred Minimum of 5 years of regulatory/submission experience in the biotech or pharmaceutical industry 3 years of experience working on developmental products Knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one or more key regions (EU, US, Japan) Experience working in Regulatory Affairs with agency interaction responsibility with at least one health authority is preferred. Developing regional knowledge regarding health authority requirements, regulatory filing pathway/categories, processes, and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g., GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new, and marketed products.