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Regulatory Submission Manager at ICON plc - ApplyBlast

Regulatory Submission Manager

ICON plc

1 month ago

Sofia, Sofia City Province, Bulgaria

Onsite

Full Time

Manager

0 applicants

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About this role

ICON is seeking a Regulatory Submission Manager to lead operational submissions execution for designated clinical trials as a regional regulatory representative. The role involves driving global submission management strategies, ensuring compliance with industry and agency guidelines, and coordinating with study teams and sponsors to obtain necessary authorizations. This position requires expertise in CTIS and VEEVA submissions to support drug development efforts.

Responsibilities

Lead operational submissions execution for designated CTAs
Drive global submission management strategy and activities
Manage compilation for core package build and documentation

Skills

Qualifications

B.S./B.Sc in Pharmacy, Life Sciences, Business or Information Technology

About ICON plc

iconplc.com

Headquarters

South Dublin, Ireland

Company Size

10001+ employees

Founded

1990

View Profile

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.