Regulatory Submissions Coordinator (Senior/Experienced)

About the Role

We are seeking a full-time experienced or senior Regulatory Submissions Coordinator to join our Clinical Operations team based in Mumbai, India. Our environment fosters expertise, empowering staff to use their unique skills for proactive problem-solving and supporting business partners effectively. Employees are engaged in challenging projects with opportunities for career growth and global exposure. The work setting is primarily office-based with some hybrid options available depending on eligibility.

Company Overview

Medpace is a comprehensive clinical contract research organization (CRO) offering Phase I-IV clinical development services across biotechnology, pharmaceutical, and medical device sectors. Our mission is to expedite worldwide development of safe and effective medical therapies by advancing clinical research. We possess extensive regulatory and therapeutic knowledge in major fields such as oncology, cardiology, endocrinology, central nervous system disorders, and infectious diseases. Headquartered in Cincinnati, Ohio, we operate in over 40 countries with more than 6,500 employees.

Key Responsibilities

• Facilitate all country-specific activities to enable activation of investigative sites throughout clinical trial phases.
• Prepare, review, and submit regulatory documentation to appropriate agencies.
• Maintain active communication with global study teams regarding study progress.
• Identify potential risks to site activation and implement mitigation steps.
• Provide expert guidance in ethics and regulatory submissions to global teams.
• Review and finalize essential documents necessary for site activation.
• Serve as primary contact for ethical and regulatory submission processes.
• Engage directly with investigative sites during study startup and activation.
• Ensure all submissions adhere to relevant regulations and guidance standards.
• Advise sponsors on evolving regulatory and compliance requirements.
• Track submission progress and guarantee timely filing.

Qualifications and Skills

• Bachelor’s degree in a science discipline with over four years of regulatory submissions experience, preferably in clinical research within a CRO setting.
• Proven hands-on experience preparing, reviewing, and submitting regulatory documents to Ethics Committees and Regulatory Authorities, specifically including CDSCO and DCGI, with ability to respond to queries.
• Willingness to travel to Delhi occasionally is advantageous.
• Excellent verbal and written communication abilities.
• The role level correlates with experience: strong local regulatory submission expertise is required for the coordinator level, while regional experience within APAC is necessary for a managerial position.

Working Culture and Benefits

• Engage with physicians, scientists, and industry experts focused on advancing medical therapeutics via clinical research excellence.
• Be part of a team environment promoting decision-making, creative thought, continuous learning, transparency, and trust.
• Accessible and approachable leadership across Medpace.
• Office-based environment with onsite mentorship and well-defined career paths offering clear growth opportunities.
• Industry-recognized onboarding, training, and continuous professional development programs.
• Encouragement for employees to contribute ideas and influence change.
• Competitive compensation aligned with performance.
• Comprehensive health, wellness, retirement, and paid time off benefits.
• Flexible work arrangements post-training for eligible positions, including occasional work from home.
• Company-sponsored social events foster a strong community.

Additional Information

Benefits may differ based on country location. Candidates selected for interviews will be contacted; others will not receive individual responses.