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.
Gujarat :
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Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Delhi | India | New Delhi | PAN-India |Assam :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Leiden |Netherlands :
Netherlands |Remote Australia :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Khulais | Riyadh | King Abdullah Economic City | Jeddah | Najran | Rabigh |Kuala Lumpur :
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Niš |Bohemia :
Prague |Chile :
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