Job Summary

We are currently seeking a full-time, office-based Experienced/ Senior Regulatory Submissions Coordinator to join our Clinical Operations team in India, Mumbai.

Office based with hybrid work arrangements based on eligibility.

Responsibilities

- Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials;
- Prepare, review, and submit to Regulatory Agencies;
- Communicate with global study teams and personnel on study progress;
- Ability to effectively identify risks to site activations and mitigate as necessary;
- Provide expertise and guidance to global study teams in ethics and regulatory submissions;
- Review and finalize essential documents required for site activation;
- Act as a main contact for Ethical and Regulatory submission-related activities;
- Direct contact with investigative sites during the study start up and activation process;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise sponsors on changing regulations and compliance requirements; and




- Track submissions and ensure timely filing of documents.

Qualifications

- Bachelor's degree in science field and more than 4 years of regulatory submissions experience in clinical research, preferably with a CRO.
- Hands-on experience preparing, reviewing, and submitting regulatory documentation to ECs and RA (minimum CDSCO and DCGI); including formulating responses to queries.
- Open to travel to Delhi on a monthly basis will be a plus point.
- Solid oral and written communication skills.
- Position commensurate with experience. Strong local experience mandatory for Regulatory Submissions Coordinator level, Local and Regional APAC experience mandatory for a Regulatory Submissions Manager level.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Regulatory Submissions Coordinator (Senior/ Experienced) (Navi Mumbai)
🏢 Medpace Clinical Research India
📍 Navi Mumbai