Clinical Trial Submission Manager Associate - Ankara
7 saat önce
İş tanımı
Clinical Trial Submission Manager Associate
ICON 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 Regulatory Affairs Specialist to join our diverse and dynamic team. As a Regulatory Affairs Specialist at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
- Notification to ECs and RA, Post activities management
- Amendment submission to ECs and RA. This will include submission via RA portal.
- EC submission: printing & shipping of the dossiers (initial, amendments and notifications) for ECs requiring paper versions
- Management of payment to ECs and follow-up on invoices
- Follow-up communication with ECs : RFI, approval
- Candidate needs to be fluent in Turkey process.
- Position is 100% office based (Istanbul) to manage printing and shipment requirements and support to RSMs
- Person may be involved in global activities (RFIs, payments).
Your profile
Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
Minimum of 1-2 years of experience in regulatory affairs within the pharmaceutical or biotechNlogy industry.
Proficiency in regulatory submission processes and requirements, including CT/IND, MAA/NA, variations, DSUR, PSUR, and renewals.
Familiarity with label review, translation requirements, and regulatory intelligence activities.
Strong attention to detail and excellent communication skills.
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
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.
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