Country Approval Specialist
Country Approval Specialist
Thermo Fisher Scientific
Job description
Looking to build a career in clinical trial regulatory submissions? Explore this Country Approval Specialist role at Thermo Fisher Scientific, based remotely in India.
Company Description
Thermo Fisher Scientific is a leader in scientific research and clinical innovation. The Company enables customers to make the world healthier, cleaner and safer by researching, developing and delivering life‑changing therapies. It has trials in more, than 100 countries. Thermo Fisher Scientific’s PPD clinical research portfolio covers laboratory, digital and decentralized trial services. It continues advancing global healthcare through scientific excellence.
Job Summary
This fully remote role supports clinical study startup and regulatory submissions within Clinical Operations. As a Country Approval Specialist, you will manage the preparation, review, and coordination of country submissions in line with global submission strategy. Your work will ensure full compliance with DCGI and Ethics Committee requirements. The role focuses on activating investigative sites accurately and on schedule across assigned studies.
Key Responsibilities
Prepare and review country specific submission dossiers for DCGI and EC approvals.
Execute submission strategies and forecast regulatory approval timelines.
Coordinate submissions to ensure timely activation of investigative sites.
Maintain strong attention to detail while ensuring submission accuracy.
Track submission status using relevant tracking databases and systems.
Support negotiation and documentation related to grant budgets and payment schedules.
Prepare and review informed consent forms and patient information sheets.
Support site start up documents and ethics submission packages.
Follow PPD SOPs and required regulatory compliance standards.
Coordinate closely with cross functional teams to keep submissions on track.
Educational Qualification
Bachelor's degree in life sciences, or a related scientific field.
Skills Required
Strong expertise in clinical trial regulations and regulatory documentation.
Experience with country level regulatory submissions, ideally in India.
Strong understanding of DCGI and Ethics Committee submission requirements.
Good cross functional collaboration and communication skills.
Strong organizational skills and close attention to detail.
Comfortable using regulatory tracking databases and related systems.
Salary Structure
The average salary for a Country Approval Specialist (or Associate) at Thermo Fisher Scientific in India typically ranges from ₹4.5 Lakhs to ₹7.5 Lakhs per year.
Career Development
This role offers hands on exposure to global clinical trial regulatory submissions within a company trusted by top pharma and biotech firms. Thermo Fisher also supports long term growth through mentorship, structured processes, and opportunities to advance within regulatory and clinical operations.
How to Apply
Visit our job portal and search for the Country Approval Specialist role - Thermo Fisher Scientific.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
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