Job Overview:
We are seeking a highly motivated Local Regulatory Contact to join our team.
The successful candidate will work closely with internal and external project teams, collaborating on local and international projects across various therapeutic areas.
* Perform clinical study application submissions in Germany, Austria, and Switzerland, including both medicinal products and medical devices.
* Prepare and translate submission documents, such as ICFs.
* Stay up-to-date with local regulatory requirements for drug/device development and clinical study submissions.
* Provide guidance on regulatory requirements internally and externally.
This role also offers the opportunity to contribute to and coordinate regulatory and EC clinical study application submissions for multi-country trials, depending on prior experience.
Key Responsibilities:
* Monitor and manage clinical trials (phases I-IV) in compliance with protocol, ICH-GCP/ISO 14155, SOPs, and regulations.
* Perform Source Data Review (SDR), Source Data Verification (SDV), and review Case Report Forms (CRFs).
* Document monitoring visits and submit reports on time.
* Handle and distribute study supplies and products when applicable.
* Set up site budgets and agreements.
* Provide training and develop study materials.
Requirements:
* Bachelor's degree or equivalent in a relevant field.
* Knowledge of ICH-GCP, ISO 14155, and national regulations.
* Experience in clinical trials submissions locally and internationally, preferably including the UK.
* Fluency in the local language and English is essential.
What We Offer:
* A challenging position in a European CRO with a strong local presence.
* Ongoing professional development opportunities.
* A great working environment with dedicated colleagues.