Regulatory Submissions Manager - Turkiye

Regulatory Submissions Manager (EU CTR)

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 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

Responsibilities and Accountabilities:

• Lead the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications, ensuring full compliance with local and global regulatory requirements.

• Develop and implement regional clinical trial regulatory strategies aligned with global development objectives and timelines.

• Provide strategic input to clinical study teams and Global/Regional Regulatory Leads (GRL/RRL) to ensure trial design, documentation, and execution meet regional regulatory expectations.

• Serve as primary regulatory contact with local health authorities (e.g., ANVISA) for clinical trial submissions, queries, and approvals.

• Collaborate closely with the Clinical Trial Unit RA, Early Development, Clinical Operations, and Global Regulatory Affairs to ensure timely submissions, approvals, and updates for ongoing clinical studies.

• Prepare, review, and ensure the quality, scientific integrity, and regulatory compliance of technical and administrative documentation supporting CTAs/INDs.

• Monitor and interpret changes in clinical trial regulations, guidelines, and regulatory trends in assigned region, and proactively communicate implications to project teams.

• Support regulatory inspections, audits, and compliance activities related to clinical trial conduct and documentation.

• Contribute to cross-functional initiatives to enhance regulatory efficiency, harmonize submission processes, and maintain best practices across regions.

• Provide mentorship and regulatory guidance to internal stakeholders on regional regulatory processes and expectations for clinical trial approvals and maintenance.

• As agreed with regional or global regulatory management, may provide support for clinical trial submissions and maintenance activities in other countries within the assigned region.

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 biotechnology 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized 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