Regulatory Submissions Coordinator
Regulatory Submissions Coordinator
Medpace
Job description
Looking to advance your career in regulatory submissions and CRO operations? Explore this Regulatory Submissions Coordinator role at Medpace in Navi Mumbai.
Company Description
Medpace is a leading Contract Research Organization. Medpace offers Phase I through Phase IV clinical development services to pharmaceutical, biotechnology and medical device companies. With more than 6,500 employees in over 40 countries Medpace helps speed up the development of safe effective medical therapies worldwide. The company brings in‑country regulatory and therapeutic expertise across major clinical research areas.
Job Summary
This senior or experienced role is based in Navi Mumbai within the Medpaces Clinical Operations team. As a Regulatory Submissions Coordinator you will be responsible for managing site activation, ethics committee filings and regulatory dossier submissions for trials across all phases: Phase I through Phase IV. You will work directly with CDSCO and DCGI requirements via the SUGAM portal. Your role will involve coordination with study teams, throughout the entire trial process.
Key Responsibilities
Manage site activation activities for trials across different phases.
Prepare and submit regulatory documentation to relevant health authorities.
Handle ethics committee filings as part of the site activation process.
Review essential documents required to activate study sites.
Coordinate CDSCO and DCGI submissions through the SUGAM online portal.
Collaborate with study teams to keep submissions on track.
Provide expertise and guidance to internal teams as needed.
Ensure timely submission of required documents.
Maintain records of all regulatory filings and correspondence.
Educational Qualification
Bachelor's or Master's degree in Science, Pharmacy, or Life Sciences.
Skills Required
4 or more years of hands‑on experience in regulatory submissions EC filings and site activation within a CRO or pharma company.
Deep understanding of CDSCO, DCGI and SUGAM portal procedures.
Strong knowledge of clinical trial regulatory framework.
Good communication and coordination skills to work with teams.
Strong attention to detail and document accuracy.
Ability to manage submissions and deadlines at once.
Salary Structure
The estimated average annual salary of Regulatory Submissions Coordinator at Medpace is typical reported ranges between ₹9.16 Lakhs and ₹9.97 Lakhs per year.
Career Development
This role offers hands‑on exposure to India's submission process within a respected global CRO. Medpace also supports long‑term growth through processes, mentorship and opportunities to build deeper expertise in clinical regulatory affairs.
How to Apply
Visit our job portal and search for the Regulatory Submissions Coordinator role - Medpace.
Click on the job posting to read all the details, about the job.
Fill in your details. Upload your updated resume.
Send your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
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