Regulatory Submissions Coordinator

MEDPACE SINGAPORE PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

MEDPACE SINGAPORE PTE. LTD. is seeking a full-time Regulatory Submissions Coordinator to join our Clinical Operations team in Singapore.

You will prepare, review, and submit regulatory documents to ethics committees and regulatory agencies, ensuring timely filings and compliance across trial phases. Key duties include coordinating with global study teams, identifying and mitigating activation risks, and acting as the main liaison for submission activities with regulatory bodies.

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.

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.

Skills

Organization

Communication

ICH-GCP knowledge

Regulatory guidelines

Microsoft Office

Education

Bachelor's degree in science

Tools

Microsoft Office

Job description

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;