Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Site Activation & Maintenance team in soon to be opened office in Osaka, Japan. This position plays a key role in the clinical trial management process at Medpace. 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.
We offer the following:
- Customized training program;
- Hybrid work style and adaptable working hours;
- Annual company bonus;
- Annual merit salary increases;
- Defined Contribution Plan;
- Group term life insurance;
- Insurance association benefits available;
- Clear pathways for career growth, with opportunities to step into leadership roles;
- Collaboration with a diverse, international team and gain global exposure;
- Many additional perks unmatched by other CROs
Responsibilities
- Efficiently manage and successfully execute all aspects of global project start-up;
- Perform quality checks on submission documents and site essential documents;
- Prepare and approve informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges;
- Present during bid defenses, general capabilities meetings, and audits.
Qualifications
- Bachelor's degree or Master's/PhD degree within Life Sciences and more than 5 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;
- Strong oral and written communication skills.
- Knowledge of pharmaceutical industry, International Conference on Harmonization guidelines, and FDA or applicable local regulations.
- Possess thorough understanding of regulatory submissions activities;
- Demonstrated ability to organize, instruct and supervise a team in the completion of multiple tasks/projects;
- Native level Japanese (JLPT N1) is standard, a minimum English TOEIC score of 500 or equivalent.
Travel: Minimal
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 5,900 people across 40+ countries.
Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we've 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.
Medpace Perks
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Awards
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- The 2025 SCRS Eagle Award recipient, recognized for the outstanding partnership with clinical research sites
- 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.
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