Regulatory Submissions (Study Start-up) Coordinator

Regulatory Submissions (Study Start-up) Coordinator

Job Summary

Our clinical activities are growing rapidly, and we are currently seeking a full-time home-based Regulatory Submissions Coordinator. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

• Prepare, review, and file clinical trial applications to domestic regulatory agencies;
• Prepare and submit responses to queries and amendments to clinical trial applications;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise sponsors and internal stakeholders on changing regulations and compliance requirements;
• Track submissions and ensure timely filing of documents.

Qualifications

• Minimum Bachelor's degree in life sciences;

• At least one year of work experience as a Regulatory Submissions Coordinator for European regulation (CTR);

• Excellent organization and communication skills;

• Knowledge of Microsoft Office;

• Hands-on experience preparing, reviewing, and submitting regulatory documentation; and

• Greek (mother tongue) and very good knowledge of English.

• Medpace Overview

• Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

• Why Medpace?

• When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

• Collaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.

• Leadership throughout Medpace is both accessible and approachable

• Continuous Growth & Development

• Office based environment with on-site mentors

• Defined career paths with clear advancement opportunities

• Industry renowned onboarding and training programs designed to accelerate professional development

• Ongoing training and continuous learning opportunities throughout your career

• An environment that encourages employees to influence change, contribute ideas, and grow quickly

• Other Employee Benefits

• Competitive compensation programs that recognize and reward performance

• Comprehensive health, wellness, retirement, and PTO benefits

• Office based culture with occasional WFH that provides flexibility for eligible positions after training

• Company-sponsored social events

• Please note benefits may vary based on country.

• What to Expect Next

• A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.