Regulatory Affairs Specialist for Cell Therapy

Cell2Cure is looking for a regulatory affairs specialist to facilitate our regulatory process, thereby driving Cell2Cures cell therapy towards pivotal clinical testing.

We expect you to have a high professional commitment, to be structured, and have strong analytical skills, and to have an interest in regulatory affairs and cell therapy.

Ideally you hold a master’s degree in health- or life sciences, and you have experience in authoring regulatory documentation for submission to
authorities. You have IT skills and preferably prior experience with regulatory databases. Excellent communication skills in spoken and written English is a requirement.

You will help ensure that Cell2Cures regulatory process for clinical trial submissions is carefully planned and fulfilled. You will handle compilation of data, document writing, submissions and planning of competent authority advice.

We can offer you a position where you can help make a difference for colleagues and patients alike. You will be part of a hectic but committed innovative environment with a strong interdisciplinary collaboration. We guarantee you, that no two working days are the same.

Cell2Cure

Cell2Cure is a small Danish biopharmaceutical company that develops and produces investigational medicinal products based on stem cells isolated from adipose tissue. Today, our cell products are being tested in multiple clinical trials and diseases, nation-wide.

We are at the forefront of the development of clinical stem cell therapy. That requires drive and creativity and is rewarded with great responsibility and influence on decision making. You will be given an active role in a small group of dedicated entrepreneurs and developers, all with many different tasks, and the skills to pull together.

The job

You will help ensure that Cell2Cure products and clinical trials meet the current European requirements for Advanced Therapy Medicinal Products.

This will include tasks such as:

• Advise on strategies and requirements for clinical trial applications
• Guidance and knowledge-sharing with Cell2Cure organization regarding regulatory requirements
• Optimization of submission processes
• Ensuring timely readiness for regulatory applications and submissions
• Gathering and compilation of information by collaboration with Cell2Cure colleagues
• Writing, editing and compilation of clinical, non-clinical and quality documentation in all CTD modules
• Submitting regulatory dossiers
• Preparation of authority consultations
• Authoring and editing documentation for authority consultations
• Staying up-to-date with regulation

In return, we offer you a job with multiple branches of learning, and the possibility to influence progress in collaboration with a dedicated team.

Interested?

If you wish to be at the forefront of Danish translational stem cell development, where challenges are huge and the pace is fast, but commitment exceeds both, – we look forward to receiving your application.

We will process applications as we receive them and will have interviews with qualified candidates as we identify them, so please send your application as soon as possible.

For any further questions, please do not hesitate to contact Annette Ekblond telephone no. +45 21 78 28 24.

Cell2Cure is currently expanding. You will be one of several new colleagues also associated with production, quality control and regulatory affairs.