Regulatory Submissions Coordinator (Remote)

Medpace; United States; Remote; USD 18,000 - 33,000; Full time

Benefits offered by this job

WFH flexibility

Job summary

Medpace is seeking a full-time, remote Regulatory Submissions Coordinator to support our Clinical Operations team in South Africa. The role focuses on preparing, reviewing, and filing regulatory submissions, coordinating with research sites, and ensuring adherence to regulations and timelines.

Ideal candidates will have a life sciences degree, at least one year of experience, strong organizational and communication skills, and proficiency with Microsoft Office and regulatory documentation

Qualifications

• Bachelor's degree preferably in life sciences
• At least one year of experience
• Excellent organization and communication skills
• Knowledge of Microsoft Office
• Hands-on experience preparing, reviewing, and submitting regulatory documentation
• Very good knowledge of English

Responsibilities

• Prepare, review, and file clinical trial applications to domestic and international regulatory agencies
• Communicate with research sites in South Africa
• Ensure submissions comply with applicable regulations and guidance documents
• Advise sponsors on changing regulations and compliance requirements
• Track submissions and ensure timely filing of documents
• Provide support for feasibility

Skills

Bachelors in Life Sciences

Organizational skills

Communication skills

Microsoft Office

Regulatory submissions

English proficiency

Education

Bachelor's degree in life sciences

Job description

Medpace is seeking a full-time, remote Regulatory Submissions Coordinator to support our Clinical Operations team in South Africa. The role focuses on preparing, reviewing, and filing regulatory submissions, coordinating with research sites, and ensuring adherence to regulations and timelines.

Ideal candidates will have a life sciences degree, at least one year of experience, strong organizational and communication skills, and proficiency with Microsoft Office and regulatory documentation