We are currently seeking a full-time, office-based* Experienced/ Senior Regulatory Submissions Coordinator to join our Clinical Operations team in India, Mumbai.
Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with compelling projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team.
*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 formulati