Regulatory Manager / Senior Regulatory Manager

📋 Description

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including, but not limited
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or
• Serve as representative of Global Regulatory Affairs at project team meetings with both external
• Works within a project team, and where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted

🎯 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
• Informed knowledge of all aspects of the drug development process inclusive of regulatory
• Candidates must have regulatory affairs experience working for a CRO or within the Pharmaceutical
• Ability to understand clinical and pre-clinical study results, to help in its interpretation for
• Knowledgeable of clinical trials methodology, including a working knowledge of protocols and