Country Approval Specialist in India at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Country Approval Specialist based in India.

This role supports the coordination and execution of country-level regulatory and ethics submissions for clinical studies.
You will help ensure submissions are prepared accurately and aligned with global study strategies and local requirements.
Working across internal teams and study sites, you will contribute to keeping site activation activities on track.
The position offers exposure to clinical research operations, regulatory processes, and cross-functional collaboration.
You will help maintain high standards of documentation, compliance, and trial status reporting throughout the study lifecycle.
The role is well suited to someone who is organized, detail-oriented, and motivated to build expertise in clinical research and country start-up activities.
You will work in a collaborative environment where effective communication and timely execution directly support successful clinical studies.

• Prepare, review, and coordinate local Ethics Committee submissions under guidance and in accordance with the global submission strategy.
• Support the preparation of local Ministry of Health or other regulatory submissions, where applicable.
• Coordinate with internal functional teams to align site start-up activities, submission activities, and agreed timelines, ensuring submissions remain aligned with the critical path for site activation.
• Work toward established country and site submission cycle-time targets.
• Communicate with investigators, where required, regarding submission-related activities.
• Serve as a country-level contact for selected ethics or regulatory submission activities, as assigned.
• Collaborate with start-up Clinical Research Associates (CRAs) to prepare regulatory compliance review packages when applicable.
• Assist with the development of country-specific Patient Information Sheets and Informed Consent Forms.
• Support the negotiation and coordination of site grant budgets and payment schedules.
• Accurately enter and maintain trial and site activation status information in internal or client tracking systems.
• Establish and maintain local country study files and filing processes in accordance with applicable procedures and client requirements.
• Maintain current knowledge of internal procedures, client requirements, and applicable regulatory guidelines relevant to the services provided.

• Bachelor’s degree or equivalent qualification, preferably in a relevant scientific, healthcare, life sciences, or related discipline.
• 0–2 years of relevant experience, or an equivalent combination of education, training, and directly related experience.
• Strong written and verbal communication skills, with good English language and grammar proficiency.
• Excellent interpersonal and collaboration skills, with the ability to work effectively with internal teams, sites, investigators, and other stakeholders.
• Strong attention to detail and a commitment to accurate, high-quality documentation.
• Good negotiation, organizational, and planning skills.
• Comfortable using standard computer applications and able to learn new software and tracking systems quickly.
• Basic knowledge of medical terminology and therapeutic areas.
• Basic understanding of applicable national or regional regulatory requirements and Ethics Committee regulations.
• Ability to work independently under direction as well as effectively within a team environment.
• A proactive, quality-focused approach with the ability to manage priorities and meet established timelines.

• Fully remote work arrangement within India.
• Full-time position with a standard Monday–Friday schedule.
• Opportunity to gain hands-on experience in clinical research, regulatory submissions, and country start-up activities.
• Exposure to global study teams and cross-functional collaboration.
• Professional development and opportunities to build expertise in clinical trial operations and regulatory processes.
• Inclusive and collaborative work environment focused on innovation, scientific advancement, and employee development.
• Supportive workplace committed to accessibility, equal opportunity, and career growth.