Country Approval Specialist – Clinical Research
Job ID: R-01331388
Job Type: Full-Time
Category: Clinical Research / Regulatory Affairs / Study Start-Up
Work Mode: Fully Remote
Location: Mumbai, Maharashtra, India
Job Overview
A leading global Contract Research Organization (CRO), part of the PPD® Clinical Research portfolio at Thermo Fisher Scientific, is seeking a Country Approval Specialist to support clinical trial start-up activities in India. This role is critical to ensuring timely regulatory and ethics approvals and optimizing study start-up timelines across global clinical research programs.
The successful candidate will bring strong expertise in clinical operations and regulatory submissions, along with in-depth knowledge of Indian regulatory requirements, including DCGI and Ethics Committee processes.
Key Responsibilities
Prepare and manage country-specific regulatory submission dossiers for DCGI and Ethics Committees (EC) in compliance with local and global clinical trial regulations
Execute submission strategies to obtain regulatory and ethics approvals within defined timelines
Forecast and track regulatory timelines for critical study start-up milestones
Liaise with regulatory authorities, investigators, and site staff to facilitate approval processes
Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Project Management to ensure accurate and timely documentation
Collect, review, and maintain essential regulatory documents, ensuring timely system updates and compliant filing
Monitor compliance with Indian regulations, ICH-GCP, and applicable international guidelines
Manage amendments, notifications, and ongoing regulatory submissions throughout the study lifecycle
Provide regulatory guidance to project teams on local requirements, timelines, and submission strategies
Education & Experience Requirements
Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific discipline
Minimum 2–4 years of experience in clinical trial start-up, clinical operations, and/or regulatory affairs
Hands-on experience with DCGI and Ethics Committee submissions in India is required
Strong understanding of Indian clinical trial regulations, ICH-GCP, and global regulatory standards
Equivalent combinations of education, training, and relevant experience may be considered
Required Skills & Competencies
Strong knowledge of clinical trial regulatory frameworks and submission processes
Excellent organizational skills with strong attention to detail
Ability to manage multiple submissions and deadlines in a fast-paced environment
Strong written and verbal communication skills
Proven ability to collaborate effectively with cross-functional and global teams
High level of accountability and problem-solving capability
Why Join Thermo Fisher Scientific
Be part of a globally recognized CRO supporting clinical trials across multiple therapeutic areas
Work in a fully remote model with global exposure
Collaborate with cross-functional international teams
Access continuous learning, career development, and growth opportunities
Contribute to research that improves patient outcomes worldwide
About Thermo Fisher Scientific
Thermo Fisher Scientific is the world leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through its PPD® Clinical Research Services, the organization delivers innovative clinical development solutions across more than 100 countries.
Thermo Fisher Scientific is an equal opportunity employer and values diversity, equity, and inclusion.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Witney |Ontario :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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