Director, Global Regulatory Affairs, Strategy
Sobre a vaga
O que você vai fazer
The Director will represent Regulatory Affairs in Clinical Trial Teams, ensuring oversight and progress of complex clinical trial submissions in the EU/ROW region. This role involves developing and executing the EU/ROW regulatory strategy for assigned compounds, including leading the preparation of strategic regulatory documents and managing EMA or national Scientific Advice procedures.
O que eles procuram
Candidates must possess a minimum of a Bachelor's degree in a scientific or health-related field, with a Master's degree preferred, and at least 8 years of Regulatory Affairs experience, preferably through global marketing authorization submissions. Essential requirements include experience planning complex clinical submission strategies, leading health authority meetings, and a strong understanding of drug development and EU regulatory procedures.