Global Regulatory Affairs Manager

vor 3 Monaten

Bergisch Gladbach, Deutschland Miltenyi Biomedicine Vollzeit

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 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 other 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 (%).

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

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.

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