Regulatory Submissions Specialist

hace 1 mes


Madrid, Madrid, España Medpace A tiempo completo

Job Summary

We are seeking a skilled Regulatory Submissions Coordinator to join our Clinical Operations team in Madrid. This role plays a crucial part in the clinical trial management process at Medpace.

Key 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.
  • Collection of essential documents and preparation of essential documents packages for drug release.
  • Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities.

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, great attention to detail.
  • Knowledge of Microsoft Office.
  • Fluency in English.

About Medpace

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 our scientific and disciplined approach.

Why Medpace?

At Medpace, we are committed to making a difference in the lives of patients and families affected by disease. We offer a dynamic work environment, competitive compensation and benefits package, and opportunities for professional growth and development.



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