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ICON plc
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Regulatory Scientist

Regulatory Scientist

ICON plc

4 - 8 years

7 - 12 Lacs

chennai

Posted:1 week ago| Platform:

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Skills Required

cro pharmaceutical compliance regulatory regulations regulatory affairs ctms veeva

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are looking for a highly skilled Regulatory Scientist to join our team in India. The ideal candidate will have 4 to 9 years of experience supporting regulatory submissions for clinical trials and ensuring alignment with applicable regulatory frameworks.

Roles and Responsibility

Support and execute regulatory submissions for phases 1 to 3 clinical trials in India.
Prepare and review CT04, CT16, and related application documents through the SUGAM portal.
Manage documentation and archival systems including TMF, CTMS, and Veeva Vault.
Ensure compliance with ICH GCP guidelines and India regulatory framework including NDCT 2019.
Collaborate across internal stakeholder groups to drive submission readiness.
Monitor regulatory updates including toxicity requirements and other evolving guidelines.

Job Requirements

Bachelor's or master's degree in a scientific or healthcare discipline.
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.

Perks and Benefits

Competitive salary and benefits package.
Opportunity to work with a leading healthcare intelligence and clinical research organization.
Inclusive environment driving innovation and excellence.
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

About Company

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.

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Regulatory Scientist