Thermo Fisher Scientific is hiring a Country Approval Specialist – Clinical Operations

Thermo Fisher Scientific, a global leader in scientific research and clinical innovation, is seeking a Country Approval Specialist to join its Clinical Operations team in India (Remote – Mumbai).
This role offers a unique opportunity to lead the clinical study startup and regulatory submission process, ensuring full compliance with DCGI and Ethics Committee (EC) requirements.

If you have strong expertise in clinical trial regulations, regulatory documentation, and cross-functional collaboration, this is your chance to make a real impact in clinical research operations.

⚙️ Key Responsibilities

• Prepare and review country-specific submission dossiers for DCGI and EC approvals.
• Execute submission strategies and forecast regulatory timelines.
• Liaise with regulatory authorities, investigators, and internal stakeholders to expedite approvals.
• Obtain, verify, and manage essential study documents in compliance with GCP and SOPs.
• Ensure accurate updates and maintenance of study startup systems and trackers.
• Monitor compliance with local and international regulations.
• Manage amendments, notifications, and support ongoing clinical submissions.
• Provide guidance and regulatory insights to project teams.

🎓 Qualifications & Experience Required

• Education: Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
• Experience: Minimum 2–5 years of relevant experience in clinical operations, study startup, or regulatory affairs.
• Skills Required:
  • Strong understanding of clinical trial regulations and ICH-GCP.
  • Excellent organizational, communication, and documentation skills.
  • Ability to collaborate across global clinical teams.

💼 Why Join Thermo Fisher Scientific?

• Work in a global, innovative environment that values growth, inclusion, and scientific excellence.
• Opportunity to collaborate with world-class professionals driving healthcare innovation.
• Remote flexibility with a supportive work culture.
• Competitive compensation and career development pathways.

📝 How to Apply

Application Link