Global Regulatory Submissions Specialist

Medpace; Singapore; Hybrid; SGD 60,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Retirement benefits

WFH after training

Competitive compensation

Job summary

Medpace in Singapore is seeking a full-time Regulatory Submissions Coordinator to join our Clinical Operations team. You will perform activities to activate investigative sites and prepare regulatory submissions to agencies.

The role requires strong organization, awareness of ICH-GCP guidelines, and experience with regulatory documentation. You will interact with global study teams, ensure compliance, and support site activation throughout trials.

Qualifications

• Bachelor's degree in the science field or equivalent experience.
• Preferrably 2 years of relevant CRO/pharma study coordination experience.
• Experience in preparing and submitting regulatory applications.

Responsibilities

• Activate investigative sites across all trial phases.
• Prepare, review and submit regulatory documentation to agencies.
• Communicate with global study teams on study progress.
• Identify and mitigate risks to site activations.
• Provide guidance on ethics and regulatory submissions.
• Review essential documents for site activation.
• Serve as main contact for submission activities with ethics/regulators.
• Direct contact with sites during start-up and activation.
• Ensure submissions comply with regulations and guidance.
• Advise sponsors on changes to regulations and compliance.
• Track submissions and ensure timely filing of documents.

Skills

Regulatory submissions

ICH-GCP knowledge

Regulatory guidelines

Excellent organization

Communication skills

Microsoft Office

Education

Bachelor's degree in science

Tools

Microsoft Office

Job description

Medpace in Singapore is seeking a full-time Regulatory Submissions Coordinator to join our Clinical Operations team. You will perform activities to activate investigative sites and prepare regulatory submissions to agencies.

The role requires strong organization, awareness of ICH-GCP guidelines, and experience with regulatory documentation. You will interact with global study teams, ensure compliance, and support site activation throughout trials.