The Clinical Trial Submission Lead (CTSL) is responsible for end-to-end planning, coordination, and execution of Clinical Trial Applications (CTA) across EU CTR and Rest of the World (ROW) regions. This role ensures timely, high-quality, and compliant submissions through effective cross-functional collaboration, proactive risk management, and strong regulatory expertise.
Key Responsibilities:
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Lead end-to-end CTA project management across multiple studies and countries
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Plan, track, and deliver submissions aligned with timelines and regulatory requirements
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Manage risks, dependencies, and complexities in global regulatory environments
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Apply knowledge of EU CTR and ROW CTA requirements
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Manage core clinical and regulatory documentation
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Collaborate with cross-functional global teams
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Build and maintain stakeholder relationships and resolve conflicts
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Monitor KPIs related to timelines and deliverable quality
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Identify risks and lead quality investigations as needed
Qualifications & Experience:
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Bachelor’s degree in Life Sciences, Pharmacy, or related field
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Minimum 5+ years of industry experience in pharmaceutical, CRO, or similar
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Experience in Clinical Trial Application submissions (EU CTR & ROW)
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Strong project management experience in a global/matrix environment
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Familiarity with clinical trials and regulatory processes
Key Skills:
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Project Management & Execution
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Regulatory Knowledge (EU CTR & Global Submissions)
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Risk & Issue Management
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Stakeholder Engagement
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Strong communication and problem-solving skills
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Adaptability, resilience, and teamwork
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