Job Title: Regulatory Scientist
Location: Chennai or Bangalore, India (Office or Remote)
Job Type: Full-Time
Job Requisition ID: JR137775
Application Deadline: December 3, 2025
Company Overview:
ICON plc is a globally recognized leader in healthcare intelligence and clinical research, dedicated to advancing innovative therapies in partnership with top pharmaceutical and biotechnology organizations. We foster an inclusive, high-performing work environment that values collaboration, innovation, and excellence. Join us in shaping the future of clinical development and regulatory science.
Role Overview:
We are seeking a skilled Regulatory Scientist to support regulatory submissions for clinical trials in India. This role is critical for ensuring compliance with Indian regulatory frameworks and international guidelines, enabling the timely and efficient approval of clinical trial applications. The successful candidate will work closely with cross-functional teams to advance clinical development programs.
Key Responsibilities:
Prepare, review, and submit regulatory documentation for Phase I–III clinical trials in India, including CT04, CT16, and related application forms via the SUGAM portal.
Ensure accurate CTRI registration and maintain compliance with national regulations.
Manage regulatory documentation and archival systems, including TMF, CTMS, and Veeva Vault.
Ensure adherence to ICH GCP guidelines and Indian clinical trial regulations, including NDCT 2019.
Collaborate with internal stakeholders such as DI, AI, and ADCI to ensure submission readiness.
Monitor evolving regulatory guidelines and toxicity requirements to support strategic submissions.
Contribute to achieving regulatory milestones through proactive planning, effective communication, and stakeholder management.
Qualifications & Experience Required:
Bachelor’s or Master’s degree in a scientific or healthcare discipline.
Minimum 4 years of regulatory affairs experience, preferably in a CRO or clinical research environment.
Strong knowledge of CDSCO regulatory submission processes, including SUGAM and CTRI portals.
Familiarity with electronic document management systems such as TMF, CTMS, and Veeva Vault.
In-depth understanding of ICH GCP and Indian clinical trial regulations, including NDCT 2019.
Excellent attention to detail, organizational skills, and ability to manage multiple priorities and deadlines.
Strong verbal and written communication skills in English.
Why Join ICON:
Work in a globally inclusive and diverse culture that values high performance and professional growth.
Competitive salary and benefits, including health insurance, retirement planning, life assurance, and flexible country-specific perks.
Access to global Employee Assistance Programs and well-being support.
Opportunities for career development, mentorship, and participation in impactful regulatory and clinical projects.
Equal Opportunity Statement:
ICON is committed to fostering an inclusive and accessible workplace. We provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. All qualified applicants are encouraged to apply.
How to Apply:
Submit your application through our careers portal to join a global team advancing clinical research and regulatory excellence. Current ICON employees should apply via the internal employee portal.
Gujarat :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
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