Thermo Fisher Scientific Inc. is a global leader in scientific research, healthcare, and pharmaceuticals, committed to making the world healthier, cleaner, and safer. With a strong presence in over 50 countries, Thermo Fisher provides cutting-edge solutions in clinical trials, diagnostics, and biotechnology. The company fosters innovation, diversity, and professional growth, making it a top employer in the life sciences sector.
Job Openings
1. Country Approval Specialist (Fully Remote, India)
Job ID: R-01321978 | Work Schedule: Mon-Fri | Location: Remote, India
Key Responsibilities:
- Manage regulatory & ethics committee submissions for clinical trials in India.
- Ensure compliance with ICH-GCP, Indian regulations, and study startup timelines.
- Collaborate with CRAs, Clinical Trial Managers, and regulatory teams.
- Prepare and review site contracts, budgets, and essential documents.
- Maintain accurate records of approvals and documentation.
Eligibility:
- Experience in study startup, regulatory affairs, or clinical operations.
- Strong knowledge of Indian clinical trial regulations & GCP guidelines.
- Excellent organizational, communication, and negotiation skills.
- Ability to work in a fast-paced, cross-functional team.
Educational Qualification (Degree):
- Bachelor’s or Master’s degree in one of the following fields:
- Pharmacy (B.Pharm / M.Pharm)
- Life Sciences (B.Sc / M.Sc in Biotechnology, Microbiology, Biochemistry, etc.)
- Medicine (MBBS, BDS, BAMS, BHMS)
- Nursing (B.Sc Nursing)
- Other health/science-related fields
Experience Required:
- 2 to 5+ years of relevant work experience in study startup, clinical operations, or regulatory affairs in the pharmaceutical, CRO (Contract Research Organization), or biotech industry.
2. CRA Level II (Mumbai/Remote, India)
Job ID: R-01321868 | Work Schedule: Mon-Fri | Location: Mumbai/Remote
Key Responsibilities:
- Conduct on-site & remote monitoring for clinical trials.
- Ensure protocol compliance, ICH-GCP adherence, and data accuracy.
- Perform SDV, SDR, and investigational product reviews.
- Manage site relationships, regulatory documents, and audit readiness.
- Support trial close-out activities and risk-based monitoring.
Eligibility:
- Bachelor’s degree in Life Sciences / Nursing or related field.
- 3-5 years of onsite monitoring experience as a CRA.
- Strong knowledge of ICH-GCP, regulatory guidelines, and clinical processes.
- Excellent analytical, communication, and problem-solving skills.
Why Join Thermo Fisher Scientific?
✅ Global Impact: Contribute to groundbreaking healthcare & research projects.
✅ Career Growth: Opportunities for professional development & leadership.
✅ Work Flexibility: Fully remote & hybrid work options available.
✅ Inclusive Culture: Diverse, collaborative, and innovation-driven environment.
✅ Competitive Benefits: Health insurance, performance bonuses, and more.
How to Apply
Application Link For Country Approval Specialist (Fully Remote, India)
