Director, Global Regulatory Affairs, Strategy
About the job
What you'll do
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.
What they're looking for
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.