Regulatory Submissions Specialist

hace 4 semanas


Madrid, Madrid, España Medpace, Inc. A tiempo completo
Job Summary:

Medpace, a leading clinical contract research organization, is seeking a full-time Regulatory Submissions Coordinator to join its Clinical Operations team in Madrid. This role plays a crucial part in the clinical trial management process, ensuring timely and compliant submissions to regulatory authorities and Ethics committees.

Key Responsibilities:
  • Prepare, review, and file initial clinical trial applications, ensuring compliance with applicable regulations and guidance documents.
  • Advise sponsors on changing regulations and compliance requirements, providing expert guidance on regulatory submissions.
  • Track submissions and ensure timely filing of documents, maintaining accurate records and databases.
  • Collect and prepare essential documents packages for drug release, ensuring seamless coordination with internal stakeholders.
Requirements:
  • 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, with great attention to detail.
  • Knowledge of Microsoft Office and fluency in English.
About Medpace:

Medpace is a full-service 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.



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