Regulatory Submissions Manager (EU CTR)- Turkiye
IREICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
We are currently seeking a Manager, Regulatory Affairs to join our diverse and dynamic team. As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team. You'll provide regulatory guidance and operational support across various stages of drug development, including early development, agency interactions, clinical trial applications, marketing applications, and post-approval staff.
What you will be doing
Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA
EU CTR and UK-specific submissions essential experience here required
Management of activities associated with obtaining initial, amendment and other central authority approvals
Companion diagnostics, IVDR submissions, clinical performance studies experience would be beneficial
Oversee preparation of core regulatory packs.
Provide broad regulatory support across EU and UK requirements.
Provide regulatory guidance and efforts to internal teams
Participate in agency interactions and regulatory submissions
Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines
Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature
Your profile
Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred
Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechNlogy industry
Prior experience with various regulatory submissions, including CTA/IND/MAA
Ability to lead internal teams and carry out regulatory activities independently
Strong understanding of global regulatory requirements and guidelines
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 maximize 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 site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here.
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.
Are you a current ICON Employee? Please click here to apply