Country Approval Specialist

Work Schedule

Environmental Conditions

Job Description

About the Role

We seek a highly skilled Country Approval Specialist to join our Clinical Operations team in India. This outstanding opportunity lets you lead/exel in clinical operations team and collaboration. As a vital team member, you will ensure flawless execution of study startup phase, meeting all regulatory requirements and industry standards.

Responsibilities

• Determine and prepare country-specific submission dossiers for DCGI & EC meeting regulatory requirements for clinical trial submissions.
• Successfully implement submission strategies to acquire regulatory and ethics committee approvals. Forecast timelines for the critical activities. Liaise with regulatory authorities and investigators to facilitate approval processes.
• Collaborate with cross-functional teams to ensure timely and accurate documentation, optimise study startup timelines.
• Obtain and review essential documents, ensure systems updation and filing.
• Monitor and ensure compliance with local and international regulations.
• Work and drive the amendments and support the ongoing submissions, notifications for the ongoing studies.
• Provide guidance and support to project teams on local regulatory and GCP requirements, timelines and strategy.

Requirements

• Demonstrated background in clinical trials (clinical operations) study startup & / or regulatory affairs.
• Strong knowledge of clinical trial regulations and guidelines.
• Outstanding organizational skills and attention to detail.
• Ability to collaborate effectively with diverse teams.
• Excellent communication and interpersonal skills.
• Bachelor's degree in Life Sciences, Pharmacy, or a related field.

Why Join Us?

At Thermo Fisher Scientific, we offer an ambitious and inclusive work environment where your contributions are valued and recognized. You will have the opportunity to compete on a global scale, working alongside dedicated professionals to make a tangible impact. Join us and be part of a team that drives world-class research and innovation!