Regulatory Submissions Coordinator
On-siteSingapore, Singapore
Job Summary
Prepare, review, and submit regulatory applications to Ethics Committees and Regulatory Agencies while ensuring submissions comply with applicable regulations and guidance documents. Act as the main contact for ethical and regulatory submission activities, directly coordinating with investigative sites during study startup and activation. Communicate with global study teams on progress, identify risks to site activations, and mitigate issues as necessary. Provide expertise and guidance to global teams regarding ethics and regulatory submissions, advising sponsors on changing regulations and compliance requirements. Track submissions to ensure timely filing of all required documents.
Required Qualifications
- Bachelor's degree in the science field or equivalent combination of education and experience
- 2 years of relevant working experience at a CRO, Pharmaceutical Company, or an investigative site as study coordinator
- Experience in preparing and submitting regulatory applications
- Excellent organization and communication skills
- Knowledge of Microsoft® Office
- Knowledge of ICH - GCP guidelines
- Knowledge of regulatory guidelines
- Hands-on experience preparing, reviewing, and submitting regulatory documentation to Ethics Committees and Regulatory Agencies; including formulating responses to queries
- Proactive approach to role with ability and willingness to learn and be challenged
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