Regulatory Manager / Senior Regulatory Manager Full Time

Responsibilities

• Provide regulatory guidance throughout clinical development
• Compile and review applications to Regulatory Authorities
• Develop and review submission documents for Regulatory Authorities and Ethics Committees
• Serve as representative of Global Regulatory Affairs in project and business meetings
• Lead projects regionally or globally as required
• Oversee Regulatory Affairs Specialists to achieve submission targets
• Maintain project plans, trackers, and regulatory intelligence tools
• Assist in developing Regulatory Affairs Specialists and other staff
• Provide input on regulatory strategy and timelines for new studies
• Stay updated on laws, regulations, and guidelines governing drug development

Requirements

• Bachelor’s degree in scientific or healthcare discipline or equivalent experience
• 5 years regulatory experience for Manager level, 7 years for Senior Manager level
• Computer literacy (MS Office/Office 365)
• Fluent in English
• Regulatory experience in a Clinical Research Organisation
• Experience leading clinical submissions
• Knowledge of drug development and regulatory milestones
• Understanding of clinical and pre-clinical study results

Benefits

• Equal Opportunity Employer
• Flexible working locations in multiple countries
• Opportunity to work on global regulatory projects