Job Summary:
Medpace is hiring a Senior Study Start-Up Submissions Coordinator (Remote, Delhi) to lead and manage end-to-end regulatory submissions for clinical research studies across India and the APAC region. This role is ideal for professionals with strong DCGI and CDSCO experience who are passionate about clinical trial regulatory processes. Be part of a global CRO impacting life-saving therapies while working remotely from Delhi.
Key Responsibilities:
Perform close monitoring and follow-up of clinical trial submissions to DCGI; face-to-face visits required.
Facilitate meetings and support consultations with DCGI.
Manage and execute all aspects of India and Regional APAC start-up activities.
Independently interact with Sponsors, Sites, IRBs/ECs, and regulatory agencies such as CDSCO and DCGI.
Perform quality reviews on submission and essential site documents.
Prepare, review, and approve Informed Consent Forms (ICFs).
Interpret regulations to proactively resolve start-up issues and challenges.
Present during bid defenses, audits, and capabilities meetings.
Required Skills & Qualifications:
Bachelor’s degree with 8+ years of regulatory submissions experience in clinical research (CRO preferred).
Proven local and APAC regional regulatory experience mandatory.
Strong verbal and written communication skills.
Hands-on experience in regulatory document preparation, review, and submissions to ECs and regulatory agencies such as DCGI.
Ability to formulate effective responses to regulatory queries.
Perks & Benefits:
Flexible work environment (Remote)
Competitive compensation and benefits package
Attractive Paid Time Off (PTO) packages
Defined career paths with professional growth opportunities
Company-sponsored appreciation events
Comprehensive health and wellness programs
Company Description:
Medpace is a leading global Clinical Research Organization (CRO) offering Phase I-IV development services to pharmaceutical, biotech, and medical device industries. Specializing in oncology, cardiology, metabolic disorders, CNS, anti-viral, and anti-infective therapeutics, Medpace leverages its scientific excellence across more than 40 countries worldwide.
Work Mode:
Remote (based in Delhi, India)
Call to Action:
Ready to drive regulatory excellence in clinical research? Apply now to become a key contributor to Medpace’s mission in advancing global healthcare solutions.
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 | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Czech Republic | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Bhubaneswar | Rourkela |PAN-India :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Rangpo |Tamil Nadu :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Wilmington |Florida :
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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 :
Hebron | Nebraska City |Nevada :
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Kiel |Belgium :
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France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Budapest |Istanbul :
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Galway |Meath :
Dunboyne |Republic of Ireland :
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China | Quarry Bay |Hubei :
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Dalian |Republic of China :
Beijing |Shanghai Sai :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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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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North York | Australia | Uxbridge | Richmond Hill | Renfrew | Mississauga |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Be'Er Sheva | Tel Aviv | Yavne | Netanya | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
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Almaty |Remote Korea :
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Remote - Europe | Zaragoza | French | Leinster | Remote - Middle East | Remote - Africa | Remote, USA | Green Way | Switzerland | Bishop | McFarland | Melbourne | Lenexa | Remote | Remote - South America (Latin Americal) | Victoria |Bucharest :
Bucharest |Makkah :
Jeddah | Najran | King Abdullah Economic City | Rabigh | Riyadh | Khulais |Nišava District :
Niš |Singapore :
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Brazil | Sao paulo |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |