Medpace is hiring for the position of Regulatory Submissions Coordinator (Senior/Experienced) for its Clinical Operations team in Navi Mumbai, Maharashtra. The role is suitable for experienced professionals with a science-related bachelor’s degree and more than 4 years of experience in regulatory submissions within clinical research.
Candidates with hands-on experience in preparing, reviewing and submitting regulatory documents to Ethics Committees (ECs) and Regulatory Authorities (RA), including CDSCO and DCGI, can apply.
Job Details
| Company | Medpace |
|---|---|
| Designation | Regulatory Submissions Coordinator – Senior/Experienced |
| Department | Clinical Operations / Site Activation & Maintenance |
| Job ID | 12919 |
| Experience | More than 4 Years |
| Qualification | Bachelor’s Degree in Science |
| Location | Navi Mumbai, Maharashtra |
| Work Type | Full Time, Office Based |
| Work Arrangement | Hybrid may be available based on eligibility |
| Industry | Clinical Research / CRO |
Role Overview
The Regulatory Submissions Coordinator will support clinical trial site activation and maintenance activities in India. The role involves preparing and submitting regulatory and ethics documentation, coordinating with global study teams and investigative sites, tracking submissions and ensuring compliance with applicable regulatory requirements.
The position requires strong knowledge of Indian regulatory submissions and hands-on experience with CDSCO and DCGI submissions.
Key Responsibilities
- Perform regulatory activities required for activation of investigative sites across clinical trials.
- Prepare, review and submit documents to Regulatory Authorities and Ethics Committees.
- Coordinate with global study teams regarding study progress and regulatory activities.
- Identify potential risks related to site activation and support appropriate mitigation.
- Provide regulatory and ethics submission guidance to global study teams.
- Review and finalize essential documents required for site activation.
- Act as a key contact for Ethics Committee and Regulatory submission activities.
- Communicate directly with investigative sites during study start-up and activation.
- Ensure regulatory submissions comply with applicable regulations and guidance documents.
- Support sponsors with changing regulatory requirements and compliance matters.
- Track regulatory and ethics submissions and ensure timely filing of documents.
- Prepare responses to regulatory and ethics committee queries as required.
Required Qualifications
- Bachelor’s degree in a Science-related field.
- More than 4 years of regulatory submissions experience in clinical research.
- Experience working with a CRO is preferred.
- Hands-on experience in preparing, reviewing and submitting regulatory documentation.
- Experience with Ethics Committees (ECs) and Regulatory Authorities.
- Knowledge and experience with CDSCO and DCGI submissions.
- Experience in preparing responses to regulatory queries.
- Strong written and verbal communication skills.
Experience Required
- 4+ years of relevant regulatory submissions experience.
- Strong local Indian regulatory experience is required for the Regulatory Submissions Coordinator level.
- Experience with local and regional APAC regulatory submissions is required for positions at the Regulatory Submissions Manager level.
- Willingness to travel to Delhi, when required, will be an added advantage.
Required Skills
- Regulatory submissions
- Clinical research
- Site activation
- Ethics Committee submissions
- CDSCO submissions
- DCGI submissions
- Regulatory documentation
- Query response preparation
- Clinical trial start-up
- Regulatory compliance
- Risk identification and mitigation
- Stakeholder management
- Strong communication and organizational skills
Work Location
Navi Mumbai, Maharashtra, India
The position is primarily office-based. Hybrid work arrangements may be available depending on eligibility.
About Medpace
Medpace is a full-service Contract Research Organization (CRO) providing clinical development services across Phase I–IV studies for the biotechnology, pharmaceutical and medical device industries.
The company works across multiple therapeutic areas and provides clinical research and regulatory expertise in various countries.
Career & Benefits
Employees may have access to:
- Professional development and training programs
- Defined career development opportunities
- On-site mentoring
- Continuous learning opportunities
- Competitive compensation programs
- Health and wellness benefits
- Retirement and paid time-off benefits
- Company-sponsored social activities
- Hybrid work flexibility for eligible positions after training
Benefits may vary depending on the country and applicable employment terms.
How to Apply
Interested and eligible candidates can apply through the official Medpace careers portal for the Regulatory Submissions Coordinator (Senior/Experienced) position.
Candidates should highlight their experience with Indian regulatory submissions, CDSCO, DCGI, Ethics Committees and clinical trial site activation in their application.