Regulatory Lead Job Description
About Us:
We are seeking a highly motivated Regulatory Lead to join our team. As a Regulatory Lead, you will work in close collaboration with members of internal and external project teams, with local and international projects, and within a range of different therapeutic areas.
This role can also be combined with a Clinical Research Associate (CRA) position. As a CRA, you may also be outsourced to clients, and the position will involve frequent travelling related to monitoring visits.
The key responsibilities of this role include:
* Performing local clinical study application submissions in Germany mainly, but also in Austria and Switzerland.
* Preparing and translating submission documents, including Informed Consent Forms (ICFs).
* Staying up-to-date about local regulatory requirements for drug/ device development/ clinical study submissions.
* Providing guidance on regulatory requirements both internally and externally.
* Optional: Contributing to and coordinating regulatory and EC clinical study application submissions for multi-country trials.
If applicable, you will also work partly as a CRA, including:
* Monitoring and managing clinical trials in compliance with protocol, ICH-GCP/ISO 14155, SOPs, and regulations.
* Performing Source Data Review (SDR), Source Data Verification (SDV), and reviewing Case Report Forms (CRFs).
* Documenting monitoring visits and submitting reports on time.
* Handling and distributing study supplies and products when applicable.
* Setting up site budgets and agreements.
* Providing training and developing study materials.
Profile:
To be successful in this role, you will need:
* A Bachelor's degree or equivalent in a relevant field.
* Knowledge of ICH-GCP, ISO14155, and national regulations.
* Experience in clinical trials submissions for both investigational medicinal products and medical devices locally and preferably internationally.
* Experience in monitoring clinical studies and site management is preferable but not required.
* Fluency in the local language and English.
* Strong writing and IT skills.
Benefits:
We offer an exciting and challenging position in a European CRO that has a strong local presence. We value collaboration, sharing of experience, and continuous development of our employees in an international environment. You will be given meaningful tasks requiring efficient collaboration between industry, clinical, and scientific teams, and the authorities. Besides a great working environment with dedicated and supporting colleagues, we also offer a competitive compensation package and great development opportunities.
Contact Information:
If you would like to know more or have any questions about the position, please contact:
Elin Nilsson, Director Clinical Project Management
or
Trine Dyring, Director Clinical Operations