Country Approval Specialist

Position Overview

Join Thermo Fisher Scientific Inc. as a Country Approval Specialist and make a significant impact in the world of research! This is an outstanding opportunity to be part of a global leader in scientific services, where your contributions will help craft the future of healthcare and technology. Based in India, you will collaborate with world-class professionals to ensure the successful implementation of research projects while adhering to stringent approval standards.

Employment Type

• Full time

Work Schedule

• Standard (Mon-Fri)

Environmental Conditions

• Office

Key Responsibilities

As a Country Approval Specialist, you will:

• Coordinate and manage the country-specific approval processes for global clinical trials in India.
• Submit to India regulatory authority, ethics committees and coordinate, collaborate with investigator sites.
• Ensure compliance with local, national, and international regulations and optimal study startup processes.
• Collaborate with CRAs, functional leads like clinical trial manager, regulatory specialist and cross-functional teams to successfully implement projects and complete the study startup process in optimal timelines.
• Determine and strictly adhere to timelines for project approvals.
• Prepare and submit required documentation for regulatory approvals for new clinical trials and ongoing clinical trials.
• Maintain flawless records of approval processes and documentation.
• Obtain the essential documents, review and build the greenlight/activation packs to get approvals.
• Customise the site contracts, site budgets for clinical trials.
• Negotiate the legal language, study budgets with the participating sites and get the contracts executed.

Requirements

To excel in this role, you must have:

• Proven experience in a study startup, clinical operations, or regulatory role.
• Strong understanding of Indian regulatory requirements and processes, and GCP guidelines.
• Outstanding organizational and communication skills.
• The ability to strictly adhere to regulatory guidelines.
• Strong analytical skills and attention to detail.
• A collaborative approach and the ability to work effectively in a team environment.

Why Thermo Fisher Scientific

At Thermo Fisher Scientific, we are dedicated to encouraging an inclusive and collaborative environment. We appreciate diverse experiences and perspectives, which fuel our innovation and success. Our ambitious team is focused on making the world healthier, cleaner, and safer. You will have the opportunity to compete with the best in the industry and contribute to groundbreaking research.

Join us and be part of a company where your work truly matters!