ICON

Global Regulatory Affairs Lead

7 days left

Company
ICON
Location
Czech Republic, Hungary, Romania, Israel, Greece
Salary
Competitive
Posted
24 Sep 2021
Closes
24 Oct 2021
Ref
FC2021-81193
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Position Overview:

 

Due to ongoing Global expansion, our business is thriving. We are looking for enthusiastic Regulatory Affairs professionals to grow with our business.  

  

The Global Regulatory Affairs Associate (GRAA) is responsible for coordinating all Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met. This includes communicating the status of submissions to the Start-Up Lead (SUL) and working with them to mitigate risks to Sponsor deliverables.  Summary of tasks, including but not limited to: 

  • Providing the Sponsor and internal Project Team information on regulations governing the clinical trial at a project level and answering any Sponsor questions surrounding these topics.
  • Provide submission strategy to the client along with all requirements and documentation requests to actualise the proposed strategy.
  • Preparation of the Core Clinical Trial Application and perform QC on the content of all central submission packages.
  • Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and Bid Defence Meetings.

Requirements:

We are seeking an ambitious regulatory professional with experience of working as Regulatory Lead across multiple regions.  Additional requirements include: 

  • An undergraduate degree ideally in science, or health-related field.
  • Prior experience in the preparation of RA and Central IEC submissions for Clinical Trial Applications ideally across regions.
  • Expert knowledge of current regional guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
  • Fluency in written and spoken English. 


ICON is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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