Job Description

Regulatory CMC Author
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 Senior Regulatory Affairs Specialist to join our diverse and dynamic team. As a Senior Regulatory Affairs Specialist at ICON, you will play a pivotal role in ensuring regulatory compliance and facilitating the successful preparation of regulatory submissions, contributing to the advancement of innovative treatments and therapies.
What you will be doingLeading the preparation, submission, and maintenance of regulatory documents for clinical trials, drug registration and life-cycle activities. Providing expertise and guidance on regulatory requirements and standards to internal teams. Interfacing with regulatory agencies to address inquiries, submissions, and approvals. Monitoring changes in regulations and guidelines to ensure compliance and mitigate risks. Collaborating cross-functionally to support regulatory aspects of clinical trial planning and execution.

Your profileBachelor's degree in a scientific or related field; advanced degree preferred. Minimum of 3 - 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry. Strong knowledge of global regulatory requirements and guidelines for clinical trials / product registration and life-cycle activities. Proven ability to manage regulatory submissions and interactions with regulatory agencies. Excellent communication, attention to detail, and problem-solving 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.