Global Regulatory Affairs Manager - ATMP (m|f|d)

at  Miltenyi Biomedicine

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

• 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.

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 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%).
  Additional Information

Please refer the Job description for details