Job Summary:
Medpace is looking for a Study Start-Up Submissions Manager (Remote, Delhi) to manage and drive regulatory submissions and clinical trial start-up activities across India and the APAC region. This role is perfect for candidates with extensive DCGI, CDSCO, and APAC regulatory experience who are eager to influence global clinical research projects from a remote setting.
Key Responsibilities:
Perform close follow-up of Clinical Trials submitted to DCGI, including face-to-face visits.
Lead meetings with DCGI and support consultation processes as needed.
Efficiently manage all aspects of local and Regional APAC study start-up.
Independently communicate with Sponsors, Sites, IRBs/ECs, and regulatory bodies (CDSCO, DCGI).
Conduct quality checks on essential documents and submission materials.
Prepare, review, and approve Informed Consent Forms (ICFs).
Interpret and apply relevant regulations to develop proactive solutions for start-up challenges.
Represent Medpace during bid defenses, capability presentations, and audits.
Required Skills & Qualifications:
Bachelor’s degree with 8+ years of regulatory submissions experience in clinical research (preferably in a CRO).
Proven local and APAC regional regulatory experience essential.
Strong communication skills (both written and oral).
Expertise in preparing, reviewing, and submitting regulatory documents to ECs and RAs such as DCGI.
Ability to respond to complex regulatory queries.
Perks & Benefits:
Flexible remote working model
Competitive compensation and benefits package
Generous Paid Time Off (PTO) plans
Structured career development and progression opportunities
Company-sponsored events and employee recognition programs
Comprehensive health and wellness initiatives
Company Description:
Medpace is a global Clinical Research Organization (CRO) offering Phase I-IV development services to the pharmaceutical, biotech, and medical device sectors. With scientific expertise across oncology, cardiology, endocrinology, CNS, anti-viral, and metabolic diseases, Medpace accelerates therapeutic innovations worldwide, operating in over 40 countries.
Work Mode:
Remote (Based in Delhi, India)
Call to Action:
Advance your career in clinical research with Medpace! Apply today to lead impactful regulatory start-up projects and shape the future of global healthcare.
Andra Pradesh :
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Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Himachal Pradesh :
Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Czech Republic | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Kurla | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli |Odisha :
Bhubaneswar | Rourkela |PAN-India :
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Pondicherry (Puducherry) :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
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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 :
Fort Smith |California :
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 :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
Washington |Delaware :
Wilmington |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | 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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Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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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 :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
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 :
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Rostock |Munich :
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Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
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 :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
Queensland |Remote Australia :
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Amsterdam |Netherlands :
Netherlands |Noord Holland :
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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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
North York | Australia | Uxbridge | Richmond Hill | Renfrew | Mississauga |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
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 :
Saitama | Japan |Tokyo :
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Almaty |Remote Korea :
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Ciudad de México |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
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Manila |Mazovia :
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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 :
Singapore |South Africa :
Midrand | South Africa |Brazil :
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 |