Regulatory Submissions Specialist

hace 4 semanas


Madrid, Madrid, España Medpace A tiempo completo
Clinical Operations at Medpace is growing rapidly, and we are seeking a full-time Regulatory Submissions Coordinator to join our team in Madrid. This role plays a key part in the clinical trial management process. If you want to develop your career further, this is the opportunity for you.

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.

Qualifications:

- 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.

Why Medpace?

- People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

Medpace 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.

Note:

- Only CVs in English will be considered.

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