Regulatory Manager / Senior Regulatory Manager

Requirements

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
• 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
• Computer literacy (MS Office/ Office 365)
• Fluent in English
• Regulatory affairs experience working for a Clinical Research Organisation
• Experience leading Clinical Submissions
• Informed knowledge of all aspects of the drug development process
• Specialized knowledge of regulatory activities for at least one major region (EU, US)
• Ability to understand clinical and pre-clinical study results
• Knowledge of clinical trials methodology
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development

Benefits

• The opportunity to work in a growing organization serving clients researching groundbreaking cancer therapies
• Input and have ideas valued and nurtured, impacting positive change for the company
• Robust insights that inform real-time decisions—and optimize the oncology development pathway