Country Approval Specialist – Clinical Research (Remote, India)
Category: Clinical Research / Regulatory Affairs
Job Type: Full-Time
Work Mode: Fully Remote
Location: Mumbai, Maharashtra, India
Job ID: R-01336805
Job Overview
Thermo Fisher Scientific is seeking a detail-oriented Country Approval Specialist to support regulatory and ethics approvals for clinical trials in India. This role plays a critical part in ensuring timely country-level approvals by managing regulatory submissions, coordinating with authorities, and supporting study start-up activities across global clinical research programs.
As part of the Clinical Research Services team supporting the PPD® clinical research portfolio, the Country Approval Specialist will collaborate with cross-functional teams to accelerate study timelines while ensuring full compliance with local and international regulatory requirements.
Role Summary
The Country Approval Specialist is responsible for preparing, submitting, and managing country-specific regulatory and ethics committee submissions for clinical trials in India. The role ensures accurate documentation, effective stakeholder coordination, and compliance with DCGI, Ethics Committee, and GCP requirements throughout the study lifecycle.
Key Responsibilities
Prepare and submit country-specific regulatory dossiers to DCGI and Ethics Committees (ECs) in accordance with local regulatory requirements
Implement effective submission strategies to obtain timely regulatory and ethics approvals
Forecast and manage timelines for critical approval-related activities
Liaise with regulatory authorities, ethics committees, and investigators to facilitate approval processes
Collaborate with internal cross-functional teams to ensure completeness and accuracy of submission documentation
Support study start-up activities by optimizing regulatory timelines and processes
Obtain, review, and manage essential regulatory documents, ensuring accurate system updates and filing
Monitor ongoing compliance with local and international regulations throughout the study lifecycle
Manage protocol amendments, notifications, and ongoing regulatory submissions for active studies
Provide guidance to project teams on local regulatory strategy, timelines, GCP requirements, and best practices
Required Education & Experience
Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline
Minimum 2–4 years of experience in clinical trial regulatory submissions or study start-up activities in India
Proven hands-on experience with DCGI and Ethics Committee submissions
Strong understanding of ICH-GCP guidelines and Indian clinical trial regulations
Experience working within a CRO or pharmaceutical environment is preferred
Key Skills & Competencies
In-depth knowledge of Indian regulatory processes for clinical trials
Strong organizational and documentation management skills
Excellent written and verbal communication skills in English
Ability to manage multiple submissions and timelines simultaneously
Strong stakeholder coordination and problem-solving skills
Proficiency in electronic document management and clinical trial systems
High attention to detail with a strong compliance mindset
Ability to work independently in a remote work environment
Why Join Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through its PPD® clinical research portfolio, the organization conducts clinical trials in over 100 countries, offering employees meaningful work, global exposure, and long-term career development opportunities.
Equal Opportunity Statement
Thermo Fisher Scientific is an equal opportunity employer and values diversity and inclusion. All qualified applicants will receive consideration without regard to race, religion, gender, sexual orientation, disability, veteran status, or any other legally protected status.
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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 :
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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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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Bangkok |Israel :
Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
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