Country Approval Specialist – Clinical Research
Company: Thermo Fisher Scientific (PPD® Clinical Research Services)
Location: Mumbai, Maharashtra, India
Work Mode: Fully Remote
Employment Type: Full-time
Job ID: R-01331388
Experience Required: 3–6 Years
About the Organization
Thermo Fisher Scientific, through its PPD® Clinical Research portfolio, is a leading global Contract Research Organization (CRO) dedicated to accelerating the development of innovative therapies. With deep scientific and clinical expertise, the organization supports global drug development programs addressing some of the world’s most complex health challenges.
Role Overview
Thermo Fisher Scientific is seeking an experienced Country Approval Specialist to join its Clinical Operations team in India. This role is critical to the study start-up phase of clinical trials and is responsible for ensuring timely country-level regulatory and ethics approvals in compliance with local and international guidelines.
The ideal candidate will bring strong expertise in clinical operations, regulatory submissions, and country approval processes, with a proven ability to collaborate across cross-functional teams in a fast-paced, global environment.
Key Responsibilities
Prepare and submit country-specific regulatory and ethics committee dossiers in accordance with DCGI and EC requirements
Develop and execute submission strategies to obtain timely regulatory and ethics approvals
Forecast and manage timelines for critical start-up activities, ensuring adherence to study milestones
Act as a primary liaison with regulatory authorities, ethics committees, investigators, and internal stakeholders
Collaborate with cross-functional teams to ensure accurate documentation and optimized study start-up timelines
Collect, review, and maintain essential documents, ensuring timely system updates and compliant filing
Monitor ongoing compliance with local and international clinical trial regulations and GCP guidelines
Manage regulatory amendments, notifications, and ongoing submissions for active studies
Provide expert guidance to project teams on regulatory strategy, timelines, and local requirements
Qualifications & Experience
Education
Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline (required)
Professional Experience
3–6 years of experience in clinical trials, with hands-on exposure to study start-up, clinical operations, and/or regulatory affairs
Strong working knowledge of clinical trial regulations, DCGI requirements, ethics committee processes, and ICH-GCP guidelines
Proven ability to manage multiple submissions and timelines simultaneously
Experience working in a global CRO or pharmaceutical environment is highly desirable
Core Skills
Excellent organizational skills with strong attention to detail
Strong communication and stakeholder management abilities
Ability to work independently and collaborate effectively with cross-functional and global teams
Results-driven mindset with a focus on compliance and quality
Why Join Thermo Fisher Scientific
Be part of a globally recognized CRO driving innovative clinical research
Fully remote work environment with global exposure
Opportunity to work on international clinical trials with cross-functional teams
Inclusive, performance-driven culture that values expertise and professional growth
Meaningful work contributing to the development of life-changing therapies
Equal Opportunity Statement
Thermo Fisher Scientific is an equal opportunity employer and is committed to building a diverse and inclusive workplace. Employment decisions are made without regard to race, gender, age, disability, religion, sexual orientation, gender identity, or any other protected status under applicable laws.
SEO Keywords Optimized
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
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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 :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Peru | Argentina |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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