Regulatory Affairs Specialist - Ankara, Turkey - Home based
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 inNvative treatments and therapies.
What you will be doing
Clinical Trials: initial submission, lifecycle submissions: substantial amendments, notifications,
Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions
Providing input to the Regulatory Intelligence function.
Reviewing Investigational Medicinal Product Dossier (IMPD)/ Investigator’s Brochure (IB) Core Docs and labeling for clinical trials.
Collaborating with Regulatory Submissions team or cross-functional teams based on project size and nature.
Facilitating business development activities as needed
Your profile
Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
Minimum of 2-3 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.
#LI-MK1
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.
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, colour, 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