Regulatory Submissions Coordinator

We are currently seeking a full-time Regulatory Submissions Coordinator to join our Clinical Operations team in the Singapore office.

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 the science field or equivalent combination of education and experience;
• Preferably 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;