Regulatory Scientist

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 Regulatory Scientist to join our diverse and dynamic team. In this role, you will support regulatory submissions for clinical trials in India and ensure alignment with applicable regulatory frameworks, contributing to the advancement of innovative therapies in partnership with leading pharmaceutical and biotech organizations.

What you will be doing

Supporting and executing regulatory submissions for phases 1 to 3 clinical trials in India
Preparing and reviewing CT04, CT16 and related application documents through the SUGAM portal and ensuring accurate CTRI registrations Managing documentation and archival systems including TMF, CTMS and Veeva Vault Ensuring compliance with ICH GCP guidelines and India regulatory framework including NDCT 2019 Collaborating across internal stakeholder groups including DI, AI and ADCI to drive submission readiness Monitoring regulatory updates including toxicity requirements and other evolving guidelines Contributing to successful regulatory milestones through proactive planning and communication

Your profile

Bachelor s or master s degree in a scientific or healthcare discipline
4+ years of regulatory affairs experience, preferably within a CRO environment Strong knowledge of CDSCO regulatory submission processes including SUGAM and CTRI portals Familiarity with TMF, CTMS, Veeva Vault and electronic document management systems Understanding of ICH GCP and India clinical trial regulations including NDCT 2019 Strong attention to detail and communication skills with the ability to manage timelines and priorities

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What ICON can offer you:

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.

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