Regulatory Submissions Coordinator (Senior/ Experienced)

Listing expiry: 19 October 2026

About the role

Role Overview

The role supports regulatory submissions and site activation activities for clinical trials across all phases. It involves preparing, reviewing, and submitting documentation to regulatory agencies and ethics committees, coordinating with global study teams and investigative sites, ensuring compliance with applicable regulations, and tracking submissions to meet filing timelines.

Key Responsibilities

• Perform country-level activities required to activate investigative sites across all phases of clinical trials.
• Prepare, review, and submit documentation to regulatory agencies.
• Communicate with global study teams and relevant personnel regarding study progress.
• Identify risks that could delay site activation and implement appropriate mitigation measures.
• Provide expertise and guidance to global study teams on ethics and regulatory submissions.
• Review and finalise essential documents required for site activation.
• Serve as a primary contact for ethics and regulatory submission-related activities.
• Communicate directly with investigative sites during study start-up and activation.
• Ensure submissions comply with applicable regulations and guidance documents.
• Advise sponsors on regulatory changes and compliance requirements.
• Track submissions and ensure documents are filed on time.

Qualifications & Experience

• Bachelor's degree in a scientific field.
• More than 4 years of regulatory submissions experience in clinical research, preferably with a contract research organisation (CRO).
• Hands-on experience preparing, reviewing, and submitting regulatory documentation to ethics committees (ECs) and regulatory authorities (RAs), including the Central Drugs Standard Control Organisation (CDSCO) and the Drugs Controller General of India (DCGI).
• Experience formulating responses to regulatory queries.
• Strong oral and written communication skills.
• Strong local experience is mandatory for the Regulatory Submissions Coordinator level.
• Local and regional Asia-Pacific (APAC) experience is mandatory for the Regulatory Submissions Manager level.
• Willingness to travel to Delhi as needed is an advantage.

Additional Details

• The organisation provides clinical research and clinical development services for the biotechnology, pharmaceutical, and medical device industries.
• Its clinical development services cover Phase I–IV studies and therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system conditions, and antiviral and anti-infective areas.
• The organisation promotes scientific excellence, cross-functional collaboration, continuous learning, and career development.
• Employee benefits may include competitive compensation, health and wellness benefits, retirement benefits, paid time off, on-site mentoring, structured career paths, training programmes, and company-sponsored social events. Benefits may vary by country.
• The role is described as office-based, with hybrid work arrangements available subject to eligibility and occasional work-from-home flexibility for eligible positions after training.
• Applications are reviewed by the recruitment team, and candidates selected for interviews are contacted.