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

at  Miltenyi Biomedicine

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

• As Regulatory Affairs representative in a matrix organisation you will be responsible for managing investigational and approved advanced medicinal therapy products on a national or international basis (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 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 contribute relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements.
• Managing the development and maintenance of prescribing information and risk management plans completes the diverse range of responsibilities.

QUALIFICATIONS

• M.D., Ph.D., or Master’s degree in pharmacy, biology, chemistry, or a related field. An advanced degree or certificate in regulatory science is preferred, but not required.
• Several years of relevant experience in EU regulatory affairs, drug development and/or submission management with a focus on ATMPs and biologics.
• Sound business judgment and collaborative skills, as well as proven ability to interact and influence at all levels of a dynamic organization.
• Ability to build and maintain strong cross-functional relationships, to challenge traditional views while respecting best practices, and to present and argue cases in a professional and respectful manner.
• You are a self-starter with excellent organizational and communication skills in English, basic skills in German are preferred, but not required. Willingness to travel internationally (10%).
  Additional Information

Please refer the Job description for details