Regulatory Submissions Coordinator (Senior/ Experienced)

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.
• Strong 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.

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