Senior Regulatory affairs Specialist - EU CTR submission lead

Senior Regulatory affairs Specialist - Homebased in Bulgaria, Poland, UK, Spain or Portugal

As a Senior Regulatory affairs Specialist - (EU CTR submission lead)

you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

As EU CTRS Submission Specialist with additional areas as follows:

• Management of activities associated with obtaining initial, amendment and other central authority approvals
• Good experience using CTIS Portal
• 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

You will have :

• 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.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.