Pharmacist (f/m/x) - Bergisch Gladbach, Deutschland - Miltenyi Biotec B.V. & Co. KG

    Miltenyi Biotec B.V. & Co. KG
    Miltenyi Biotec B.V. & Co. KG Bergisch Gladbach, Deutschland

    vor 1 Woche

    Miltenyi Biotec B.V. & Co. KG background
    Beschreibung

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

    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
    • You will be responsible for managing and leading regional teams of regulatory affairs professionals in the EU and EMEA for new and approved products on a national or international basis.
    • This includes coordinating strategic regulatory activities with full staff and product management authority, as well as 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 oversee relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements.
    • Leading 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 have a proven track record of successfully leading and developing a team.
    • 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

    What we offer

    • A modern workplace in Bergisch Gladbach with opportunity for some mobile work. Exciting opportunities in the development of technologies with a secure future.
    • Cross-border intercultural cooperation and short communication channels
    • A collegial corporate culture and flexible working hours enable time management on your own terms
    • Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University
    • Diverse corporate benefits with regard to employee health, sport, and staff events