Regulatory Affairs Lead
1 month ago
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 be part of our mission to shape the future of clinical development.
We are currently seeking a Director, Regulatory Operations to join our diverse and dynamic team.
Job Summary: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.
You will 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.
Requirements:- Bachelor's degree in a scientific or related field;
- 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.
We offer a competitive salary and benefits package that includes various annual leave entitlements, health insurance offerings, retirement planning options, and a Global Employee Assistance Programme. Our company culture values diversity, inclusion & belonging, and we welcome all qualified applicants to apply without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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