REGULATORY AFFAIRS PROJECT MANAGER

Medpace, Inc.; Cincinnati (OH); Hybrid; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a dedicated Regulatory Project Manager to join their Cincinnati team. This role is pivotal in coordinating regulatory submissions and collaborating with diverse teams to ensure the success of drug development projects. You will leverage your expertise in regulatory affairs while enjoying a supportive environment that fosters professional growth. The company offers a hybrid work model, competitive benefits, and a commitment to making a positive impact in the healthcare sector. Join a team that values purpose, passion, and making a difference in patients' lives.

Benefits

Hybrid work-from-home options

Competitive PTO packages

Employee health and wellness initiatives

Discounts on local sports games

Modern, ecofriendly campus

Discounted tuition for UC online programs

Structured career paths

Qualifications

• Minimum 2 years of regulatory experience or PhD in life sciences.
• Knowledge of the US FDA drug/biologic approval process.

Responsibilities

• Coordinate regulatory submissions and serve as the primary contact with the FDA.
• Track and report project status, establish timelines, and lead project meetings.

Skills

Regulatory Affairs

Project Management

Communication

Problem Solving

Education

Bachelor's Degree in Life Sciences

PhD in Life Sciences

Job description

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Project Manager to join our Cincinnati team! This person will be a key member of Regulatory Affairs project teams to accomplish tasks that are instrumental to the companys success. With this opportunity, you will be able to leverage previous expertise and continue to develop your career further within the drug development industry.

Responsibilities

• Coordinate regulatory submissions and serve as the primary point of contact between Sponsors and US FDA;
• Coordinate Investigational New Drug (IND) application activities, track and report project status, and establish comprehensive program timelines;
• Schedule and lead internal and external project team meetings;
• Prepare agendas, presentation materials, and meeting minutes;
• Work closely with Regulatory Strategy Leads, Medical Writers, and Regulatory Document Specialists to execute project plans;
• Maintain clear and effective Sponsor communication, identify and anticipate possible issues and / or challenges, and work with the project team to develop solutions;
• Maintain close collaboration, interaction, and effective working relationships with Medpace functional area colleagues;
• Attend clinical operations internal meetings as the Regulatory Affairs representative; and
• Support other department initiatives as needed.

Qualifications

• Bachelors Degree in life sciences and minimum 2 years regulatory experience or PhD in life sciences;
• Knowledge of the US FDA drug / biologic approval process; and

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV 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 its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work weve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages, starting at 20+ days
• Competitive compensation and benefits package
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Discounts on local sports games, fitness gyms and attractions
• Modern, ecofriendly campus with an on-site fitness center
• Structured career paths with opportunities for professional growth
• Discounted tuition for UC online programs

Awards

Named a Top Workplace in 2024 by The Cincinnati Enquirer

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

EO / AA Employer M / F / Disability / Vets

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Project Manager • Cincinnati, OH, United States