Regulatory Submissions Specialist

hace 3 semanas


Madrid, Madrid, España Medpace A tiempo completo
Job Summary

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

Key Responsibilities:

  • Prepare, review, and submit 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 and prepare essential documents packages for drug release.
  • Maintain databases and spreadsheets to facilitate tracking and documentation of departmental activities.

Requirements:

  • A minimum of a Bachelor's degree in Life Sciences.
  • One year of work experience as a Regulatory Submissions Coordinator and/or experience in study start-up tasks.
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation.
  • Excellent organizational and prioritization skills, great attention to detail.
  • Knowledge of Microsoft Office.
  • Fluency in English.

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, employing over 5,000 people across 40+ countries.

Perks:

  • Hybrid work-from-home options (dependent upon position and level).
  • Competitive PTO packages.
  • Company-sponsored employee appreciation events.
  • Employee health and wellness initiatives.
  • Flexible work schedule.
  • Competitive compensation and benefits package.
  • Structured career paths with opportunities for professional growth.

Awards:

Recognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022, and 2023.



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