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.

• Coordinates with technical and regulatory leadership authority the regulatory activities of other RA professionals related to new and approved products, on a domestic or international basis.
• May serve as Global RA program team representative for one or more programs through development, registration and approval/post approval stages.
• Plans, performs and coordinates strategic and operational regulatory activities, and defines and ensures registration strategy and planning for selected assets.
• Manages communications and interactions with Health Authorities according to all regulatory requirements and leads Health Authority meetings incl rehearsals under supervision or independently.
• Ensures that all pharmacovigilance/regulatory requirements and all aspects of patient safety and product quality are closely monitored and fulfilled
• Oversees validated regulatory document management system and maintains product-specific attributes in compliance data base.

• 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 specific expertise in Regulatory Affairs.
• Several years of relevant regulatory and drug development experience in EU and Global Regulatory Affairs with a proven track record in the field of ATMPs and/or biologics. We appreciate your experience in Quality/CMC, regulatory 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 personalized and advanced 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 event

Diversity is the bedrock of our creativity

Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots –across various disciplines, linking different perspectives, skills, and abilities.

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability.

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.