Regulatory Submissions Manager (EU CTR)- Turkiye

Clinical Careers Page(11 days ago)

HybridFull TimeSenior$95,000 - $125,000Regulatory Affairs

About this role

The Regulatory Submissions Manager at ICON is responsible for overseeing regulatory activities related to drug development, including submissions and agency interactions within the EU and UK. The role involves providing regulatory guidance, managing approvals, and ensuring compliance with global requirements to support clinical research and marketing applications.

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Required Skills

Regulatory Submissions
EU CTR
UK Regulations
CTA/IND/MAA
Regulatory Guidance
Agency Interactions
GxP Compliance
Clinical Trials
Companion Diagnostics
IVDR

Qualifications

Bachelor's degree in a scientific or healthcare-related field
Minimum of 6 years of regulatory affairs experience

About Clinical Careers Page

iconplc.com

ICON plc is a global clinical research organisation (CRO) that provides outsourced clinical development and commercialisation services to pharmaceutical, biotechnology and medical device companies. It offers end-to-end drug and device development support — including clinical trial management across phases, data management and biostatistics, regulatory and safety/pharmacovigilance, and commercialisation and market-access services. ICON combines scientific and therapeutic expertise with technology and a scalable global operations network to accelerate development and bring therapies to patients. Clients engage ICON for integrated, experienced CRO support across the full product lifecycle.

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