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Director, Regulatory Affairs at ICON plc - ApplyBlast

Director, Regulatory Affairs

ICON plc

4 months ago

Reading, United Kingdom

Onsite

Full Time

Senior

0 applicants

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About this role

As a Director of Regulatory Affairs at ICON, you will provide strategic direction for regulatory compliance to global healthcare clients across pharma and biotech. The role involves leading complex European submissions, managing agency interactions, and developing robust regulatory strategies in alignment with business objectives.

Responsibilities

Lead regulatory affairs activities and provide strategic direction
Direct development and submission of European Marketing Authorisation Applications
Manage complex pre-marketing designations including Orphan Drug designs
Lead regulatory agency interactions and optimize meeting objectives
Overse interpretation of legislation to drive informed decision-making

Skills

Qualifications

Bachelor's degree in a relevant scientific disciplineAdvanced degree in a healthcare-related field10-12 years of experience in regulatory affairs

About ICON plc

iconplc.com

Headquarters

South Dublin, Ireland

Company Size

10001+ employees

Founded

1990

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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.