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Country Approval Specialist

3+ years
₹10 – ₹16 LPA
10 July 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Country Approval Specialist
Location: Remote, India
Job ID: R-01321978
Job Type: Full-time
Department: Clinical Research
Estimated Salary: ₹10 – ₹16 LPA (based on experience and CRO industry standards)


About the Role:
Thermo Fisher Scientific is seeking a Country Approval Specialist to support clinical trial startup and approval processes in India. This remote role is ideal for professionals with regulatory or startup experience in clinical operations who want to contribute to cutting-edge research and global health advancement. You’ll work with cross-functional teams and regulatory bodies to ensure the seamless initiation of global trials within India.


Key Responsibilities:

  • Coordinate regulatory authority and ethics committee submissions for clinical trials in India

  • Oversee and manage country-specific approval timelines and documentation for new and ongoing trials

  • Collaborate with CRAs, Clinical Trial Managers, and Regulatory Specialists to streamline study startup

  • Ensure compliance with local and international GCP, ICH, and regulatory requirements

  • Prepare and submit documentation for approvals in accordance with SOPs and project plans

  • Manage the collection and review of essential documents to build greenlight/activation packs

  • Customize, review, and negotiate site contracts and budgets; ensure timely contract execution

  • Maintain meticulous records of submission, approval statuses, and communication logs


Requirements:

  • Prior experience in Study Startup, Clinical Operations, or Regulatory Affairs

  • In-depth knowledge of Indian clinical trial regulatory processes and guidelines

  • Familiarity with GCP, ICH, and applicable national regulations

  • Excellent documentation, communication, and negotiation skills

  • Ability to prioritize tasks and meet stringent timelines

  • Strong attention to detail and problem-solving mindset

  • A collaborative team player with the ability to work remotely and independently


Why Join Thermo Fisher Scientific?

  • Be part of a global mission to make the world healthier, cleaner, and safer

  • Work in a diverse and inclusive culture where innovation thrives

  • Join a world-class CRO team powering PPD clinical research

  • Access to career development programs, global exposure, and flexible work culture

  • Make your mark in cutting-edge drug development and regulatory excellence