Clinical affairs manager Jobs in Rösrath

Company Description

Miltenyi Biomedicine is a biopharmaceutical company developing personalized chimeric antigen receptor (CAR) T-cell therapies. We are developing innovative treatments for serious life-threatening diseases and are reshaping their accessibility to patients worldwide with the goal of improving and prolonging patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, currently in pivotal clinical trials globally, is a tandem CAR T-cell product.

Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages.

Job Description

• You will be responsible for managing and leading regional teams of regulatory affairs professionals in the EU and EMEA for new and approved products on a national or international basis.
• This includes coordinating strategic regulatory activities with full staff and product management authority, as well as regional regulatory strategy and planning in line with the global regulatory strategy.
• Working closely with health authorities to coordinate, communicate and manage all regulatory interactions is another essential part of this position.
• You will also oversee relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements.
• Leading the development and maintenance of prescribing information and risk management plans completes the diverse range of responsibilities.

Qualifications

Additional Information

What we offer

We look forward to your application

If you would like to work in an open, creative and helpful team, we offer you the right environment here. We look forward to receiving your application - with your salary expectations and availability.