Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend 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, a tandem CAR T-cell product, is currently undergoing pivotal clinical trials on a global scale.

Join our highly professional global regulatory team in bringing new medicines to market and supporting our clinical development programs at all stages.

• As Regulatory Affairs representative in a matrix organisation you will be responsible for managing investigational and approved advanced therapy medicinal products on a national and international basis (focus on EU and other regions of the world).
• This includes operational responsibility for one or more investigational and/or approved products as well as providing regional regulatory strategy and planning support in line with our 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 contribute your expertise to relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements.
• Managing the development and maintenance of prescribing information and supporting risk management plans completes the diverse range of responsibilities.

• M.D., Ph.D., or equivalent degree in medicine, pharmacy, biology, chemistry or a related field. An advanced degree or certificate in regulatory science will demonstrate your expertise in Regulatory Affairs.
• Several years of relevant regulatory and drug development experience in EU Regulatory Affairs with a proven track record in the field of ATMPs and/or biologics. We appreciate your experience in Quality/CMC, submissions and/or Regulatory Information Management (RIM) systems.
• Sound business judgment and collaborative skills, as well as proven ability to interact and influence at all levels of a dynamic, growing organization.
• Ability to build and maintain strong cross-functional relationships, to challenge traditional views while respecting best regulatory practices, and to present and argue regulatory strategies and approaches in a professional and respectful manner.
• You are a self-starter with excellent organizational and communication skills in English and basic skills in German. Willingness to travel internationally (10%).

What we offer

• A modern workplace in Bergisch Gladbach with flexible working hours enabling time management on your own terms and an opportunity for limited mobile working
• Exciting opportunities in contributing to the development of future therapies
• A collegial corporate culture based on intercultural cooperation and short communication channels
• Personalized employee development program with specialist and personal training courses provided by our own Miltenyi University
• Diverse corporate benefits regarding employee health, sport and staff events

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.