Regulatory submission manager
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Global submission manager at ICON, you will contribute to drug development as part of the Regulatory Affairs team.
This position serves as the regional regulatory representative within study teams, responsible for obtaining and maintaining clinical trial authorizations for compounds in development or marketed products under investigation for new indications
What You Will Do:
You will oversee regulatory affairs workstreams, ensuring deliverables meet quality and timeline expectations.
- Key responsibilities include:
- Develop and implement regional clinical trial regulatory strategies aligned with global development objectives and timelines.
- Provide strategic input to clinical study teams and General/Regional Regulatory Leads (GRL/RRL) to ensure trial design, documentation, and execution meet regional regulatory expectations.
- Collaborate closely with the Clinical Trial Unit RA, Early Development, Clinical Operations, and Global Regulatory Affairs to ensure timely submissions, approvals, and updates for ongoing clinical studies.
- Prepare, review, and ensure the quality, scientific integrity, and regulatory compliance of technical and administrative documentation supporting CTAs/INDs.
- Monitor and interpret changes in clinical trial regulations, guidelines, and regulatory trends in assigned region, and proactively communicate implications to project teams.
- Support regulatory inspections, audits, and compliance activities related to clinical trial conduct and documentation.
- Contribute to cross-functional initiatives to enhance regulatory efficiency, harmonize submission processes, and maintain b
📌 Regulatory Affairs Manager (Armenia)
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📍 Armenia