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.
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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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Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
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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 :
Baton Rouge | Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maine :
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 :
Fulton | Milan | St. Louis |Nebraska :
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Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
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Dickinson |northeastern :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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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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Bavaria |North Rhine Westphalia :
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Saarbrucken |Saxony Anhalt :
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Kiel |Belgium :
Wavre |BULGARIA :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dún Laoghaire |Galway :
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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 :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
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Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
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 | Richmond Hill | North York | Renfrew | Uxbridge | Mississauga |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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Tallinn |Chuuk :
North Ostrobothnia :
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Turku |France :
Paris | Lyon |Attica :
Koropi | Athens |Greece :
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Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Yavne | Be'Er Sheva | Tel Aviv | Netanya |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 :
Remote, USA | Springville | Nairobi | Hammond | Faridabad | Ireland | Bountiful | Lenexa | Hungary | Xzagreb | Slovakia | Melbourne | Bishop | Remote - South America (Latin Americal) | Switzerland | Zaragoza | Remote | Thailand | Texas | Remote - Africa | Lousiana | Tulsa | Minnesota | Remote - Middle East | Remote - Europe | Blue Bell | Medan | Victoria | French | Riga | Castlebar | Leinster | Belgium | McFarland | Green Way | Manipal |Bucharest :
Bucharest |Makkah :
Najran | Riyadh | Khulais | Rabigh | King Abdullah Economic City | Jeddah |Nišava District :
Niš |Singapore :
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Peru | Argentina |Catalonia :
Barcelona |Madrid :
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