Regulatory Submissions Specialist
hace 4 semanas
Medpace, a leading clinical contract research organization, is seeking a highly skilled Regulatory Submissions Coordinator to join its Clinical Operations team in Madrid. This role plays a critical part in the clinical trial management process, ensuring timely and compliant submissions to regulatory authorities and Ethics committees.
This is an exciting opportunity for a recent graduate or experienced professional to develop and grow their career in a dynamic and growing industry.
Responsibilities:- Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees.
- 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.
- Collect essential documents and prepare essential documents packages for drug release.
- Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities.
- A minimum of a Bachelor's degree in Life Sciences is required.
- One year of work experience as a Regulatory Submissions Coordinator and/or experience in study start-up tasks is desirable.
- Hands-on experience preparing, reviewing, and submitting regulatory documentation is beneficial.
- Excellent organizational and prioritization skills, great attention to detail.
- Knowledge of Microsoft Office.
- Fluency in English.
No travel is required for this role.
Why Medpace:Medpace is a full-service clinical contract research organization (CRO) providing 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 our 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, we employ over 5,000 people across 40+ countries.
At Medpace, we offer a competitive compensation and benefits package, hybrid work-from-home options, employee health and wellness initiatives, and structured career paths with opportunities for professional growth.
We are an EO/AA employer and welcome applications from diverse candidates.
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Regulatory Submissions Specialist
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