EU Clinical Trial Regulation Submission Lead

EU CTR Submission lead

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.

I am looking to speak with Regulatory submission experts -
Interested in the new EU CTR guidelines, I believe this will be a massive area for growth and long term opportunities given the impact of EU CTR on clinical research and Regulatory affairs in Europe.

Multiple roles at Submission Lead level- I am hiring across the UK, Poland and Bulgaria and Spain initially fully dedicated to one of our global pharmaceutical clients; a client with which ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market.

As EU CTR Submission Specialist with additional areas as follows:

• Management of activities associated with obtaining initial, amendment and other central authority approvals
• Management of central/country level submissions associated with ensuring Investigational
• Product (IP) and any other clinical trial supplies can be imported and where applicable, exported
• Ensuring that IP labels are in adherence to country requirements and submitted where
• applicable
• Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate
• Tracking and reporting of central submission/approval progress in Clinical Trials Management
• System (CTMS), eTMF and other applicable systems
• Perform role of Local Reviewer in the QC process as appropriate
• If applicable for the Country, submit expeditable safety reports to RAs and central IECs in accordance with relevant legislation
• Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools
• are up to date
• Provide mentoring, training and support and coordinate resources and reviews workloads of team

• Expert knowledge of current ICH and local Regulatory Agency and/or Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
• Minimum 3 year prior experience preparing RA submissions and/or Central IEC submissions
• for Clinical Trial Applications preferred. 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.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.