Roles and 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.

Job Requirements :

- 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 ad-hoc basis will be a plus point.
- Solid oral and written communication skills.
- Position comesurate with experience. Strong Local experience mandatory for Regulatory Submissions Coordinator level, Local and Regional APAC experience mandatory for a Regulatory Submissions Manager level

📌 Regulatory Submissions Coordinator (Mumbai)
🏢 Medpace Clinical Research India
📍 Mumbai