Regulatory Submissions (Study Start-up) Manager

Overview

In this role you will lead global start-up and regulatory submissions within Clinical Operations, ensuring quality and compliance across sites. You will collaborate with cross-functional teams, leverage your CRO/clinical research experience, and influencestart-up strategies. This is a growth-focused opportunity to shape regulatory processes and improve site activation in a dynamic clinical trial landscape. You will work in a purpose-driven environment that values scientific excellence and continuous learning.

Pay / Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH after training
• On-site mentors and industry-leading onboarding and training programs
• Ongoing training and continuous learning opportunities
• Defined career paths with clear advancement opportunities

Responsibilities

• Efficiently manage and execute all aspects of global start-up processes
• Perform quality checks on submission documents and site essential documents
• Prepare and approve informed consent forms
• Review regulations to develop proactive solutions to start-up challenges
• Present during bid defenses, capability meetings, and audits

Key requirements

• Extensive experience in clinical research, preferably with a CRO
• Experience may include CRA or project management experience
• Knowledge and experience of Clinical Trial Applications within Europe
• Strong oral and written communication skills
• Team oriented approach and strong leadership skills

• Strong communication skills
• Team orientation
• Leadership
• Regulatory submissions management
• Clinical Trial Applications in Europe
• Project management experience

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