Medpace is inviting applications for the position of Regulatory Submissions Coordinator (Senior/Experienced) in Navi Mumbai, India. This opportunity is ideal for professionals with strong experience in clinical regulatory submissions, CDSCO, DCGI, Ethics Committee submissions, and clinical trial start-up activities. Candidates with CRO experience and expertise in Indian regulatory submissions can build a rewarding career with one of the world’s leading Clinical Research Organizations (CROs).
If you have experience handling regulatory submissions, ethics committee approvals, clinical trial documentation, and site activation, this Medpace job offers an excellent opportunity to work on global clinical research projects while collaborating with international study teams.
Job Details
| Particular | Details |
|---|---|
| Company | Medpace |
| Position | Regulatory Submissions Coordinator (Senior/Experienced) |
| Job Location | Navi Mumbai, Maharashtra |
| Employment Type | Full-Time |
| Work Mode | Office-Based with Hybrid Eligibility |
| Department | Site Activation & Maintenance |
| Experience Required | 4+ Years |
| Industry | Clinical Research / CRO |
Key Responsibilities
The selected candidate will:
- Manage regulatory submissions for clinical trials in India.
- Prepare, review, and submit documents to Regulatory Authorities and Ethics Committees.
- Coordinate site activation activities across different clinical trial phases.
- Communicate regularly with global study teams regarding submission progress.
- Identify regulatory risks and implement mitigation strategies.
- Review and finalize essential clinical trial documentation.
- Serve as the primary contact for ethics and regulatory submission activities.
- Coordinate directly with investigative sites during study start-up.
- Ensure submissions comply with CDSCO, DCGI, ICH-GCP, and applicable regulations.
- Support sponsors regarding changing regulatory requirements.
- Track regulatory submissions and ensure timely approvals.
Required Qualifications
Candidates should possess:
- Bachelor’s Degree in a Life Sciences or Science-related discipline.
- Minimum 4 years of regulatory submissions experience in Clinical Research.
- Previous experience working in a CRO is highly preferred.
- Hands-on experience with:
- CDSCO submissions
- DCGI submissions
- Ethics Committee (EC) submissions
- Regulatory Authority documentation
- Query response preparation
- Excellent written and verbal communication skills.
- Willingness to travel to Delhi monthly (preferred).
- Experience in APAC regulatory submissions will be advantageous for senior-level roles.
Preferred Skills
- Clinical Trial Start-Up
- Regulatory Affairs
- Site Activation
- Clinical Operations
- Ethics Committee Coordination
- Regulatory Documentation
- Global Clinical Trial Coordination
- Risk Assessment
- ICH-GCP Compliance
- Clinical Research Regulations
Why Join Medpace?
Medpace offers employees an environment focused on innovation, continuous learning, and career growth.
Benefits include:
- Competitive salary package
- Hybrid work flexibility after training
- Comprehensive health and wellness benefits
- Career advancement opportunities
- Industry-leading onboarding and training
- Global exposure in clinical research
- Collaborative international work environment
- Paid leave and employee wellness programs
- Company-sponsored social events
Why This Opportunity is Important
Regulatory submissions professionals play a vital role in ensuring that clinical trials receive timely approvals from health authorities and ethics committees. This position offers exposure to multinational clinical studies while strengthening expertise in Indian clinical trial regulations, CDSCO guidelines, DCGI submissions, and site activation processes.
Professionals with experience in Regulatory Affairs, Clinical Operations, Start-Up, or Site Activation can significantly advance their careers through this opportunity.
How to Apply
Application Link Through naukri
