Director, Regulatory Operations 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 Director, Regulatory Operations to join our diverse and dynamic team.
As a Director, Regulatory Operations 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 Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines. Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications. Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process. Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation. Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development. Your profile Bachelor's degree in a scientific or related field; advanced degree preferred. 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry. Strong understanding of global regulatory requirements and guidelines. Proven track record of successful regulatory submissions and approvals. Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies. Proven leadership experience. 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, 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 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.
#J-18808-Ljbffr