Company Description
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.

Job Description

• 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.

QUALIFICATIONS

• 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%).
  Additional Information

Please refer the Job description for details