Country Approval Specialist

Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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! Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.