Regulatory Affairs Manager (Clinical Trials)
Full-time
ICON Strategic Solutions
Remote
- Remote job
Regulatory Submissions Manager
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.
Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA
- Provide regulatory guidance and efforts to internal teams
- Participate in agency interactions and regulatory submissions
- Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines
- Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature
Bachelor's degree in a scientific or healthcare-related field; Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechNlogy 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
Must have experience overseeing preparation of core regulatory packs for Canada
Experience is Companion diagnostics, IVDR submissions, clinical performance studies is preferred
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. 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. 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
Vacancy posted 9 days ago
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