Regulatory Scientist – India (Office or Home-Based)
Locations: Chennai, India | Bangalore, India
Employment Type: Full-Time
Experience Required: Minimum 4 years in Regulatory Affairs (CRO experience preferred)
Overview
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking an experienced Regulatory Scientist to support regulatory submissions for clinical trials across India. This position plays a critical role in ensuring compliance with national and international regulatory frameworks and enabling the development of innovative therapies for global pharmaceutical and biotech partners.
This role is available in both office-based and home-based formats, offering flexibility and high-impact responsibilities within a collaborative and growth-driven environment.
Key Responsibilities
Support and execute regulatory submissions for Phase I–III clinical trials in India.
Prepare and review CT-04, CT-16, and related regulatory documents via the SUGAM portal.
Ensure accurate and compliant CTRI registrations for clinical trial approvals.
Manage documentation and archival systems including TMF, CTMS, and Veeva Vault.
Ensure full compliance with ICH GCP, NDCT 2019, and the Indian regulatory framework.
Collaborate with internal teams (including DI, AI, ADCI functions) to maintain submission readiness.
Track emerging regulatory updates, including toxicity requirements and evolving guidelines.
Contribute to regulatory milestones through strategic planning, risk identification, and timely communication.
Candidate Profile
Bachelor’s or Master’s degree in a scientific, pharmaceutical, or healthcare discipline.
Minimum 4 years of regulatory affairs experience, preferably in a Clinical Research Organization (CRO).
Strong understanding of CDSCO submission processes, SUGAM and CTRI portals.
Hands-on experience with TMF, CTMS, Veeva Vault, and other electronic documentation platforms.
Strong working knowledge of ICH GCP, NDCT 2019, and India-specific clinical trial regulations.
Excellent documentation, communication, organizational, and time-management skills.
What ICON Offers
ICON provides competitive compensation and a comprehensive benefits package tailored to support employee well-being and professional growth. Benefits may include:
Multiple annual leave options
Health insurance packages for employees and families
Retirement and financial planning programs
Global Employee Assistance Programme (TELUS Health)
Life assurance
Flexible, country-specific optional benefits including travel support, fitness programs, childcare support, and more
ICON is committed to fostering an inclusive, diverse, and accessible work environment with equal opportunities for all applicants.
Equal Opportunity and Accessibility
ICON provides a workplace free from discrimination and harassment. All qualified candidates will receive equal consideration regardless of gender, race, religion, nationality, disability, or veteran status. Reasonable accommodations are available upon request for candidates with disabilities.
Application Information
If you are passionate about regulatory science and clinical development, we encourage you to apply—even if you do not meet every requirement. You may be the ideal fit for this role or a related opportunity at ICON.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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Bilaspur | Eot Municipality | Raipur |Delhi :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Wilmington |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
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Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Dickinson |northeastern :
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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |United States :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Wavre |BULGARIA :
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Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
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Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Arkansas | Remote Australia |Republic of Western Australia :
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Amsterdam |Netherlands :
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Haarlem |North Brabant :
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Leiden |North Yorkshire :
Harrogate |Oxfordshire :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
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Australia | North York | Renfrew | Mississauga | Uxbridge | Richmond Hill |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
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Turku |France :
Paris | Lyon |Attica :
Athens | Koropi |Greece :
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Jakarta |Israel :
Kfar Saba | Netanya | Tel Aviv | Yavne | Be'Er Sheva |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
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Almaty |Remote Korea :
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Auckland |Lima Region :
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Warsaw |Remote :
Zaragoza | Remote - Europe | Remote - Middle East | Springville | Bountiful | Minnesota | Slovakia | Lousiana | Riga | Blue Bell | Remote - Africa | Faridabad | Green Way | Belgium | Ireland | Texas | Thailand | Melbourne | Remote, USA | Tulsa | Switzerland | Nairobi | Bishop | Remote | McFarland | Lenexa | Hungary | Hammond | Leinster | Medan | Victoria | Xzagreb | Remote - South America (Latin Americal) | French | Manipal | Castlebar |Bucharest :
Bucharest |Makkah :
Jeddah | Rabigh | Riyadh | Khulais | Najran | King Abdullah Economic City |Nišava District :
Niš |Singapore :
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Midrand | South Africa |Brazil :
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Peru | Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
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Kyiv |Dubai :
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