Overview
In this role you will lead the development and lifecycle management of syringe and safety system platforms, driving innovation for patient-centric delivery solutions. You will work across development, manufacturing, quality, and external partners to meet project milestones and influence regulatory strategy. You’ll shape platform strategies to maximize reuse while supporting diverse programs and manage platform-level risks and improvements. This is an opportunity to impact lifesaving therapies at scale, combining device technology with pharmaceutical development.
Leistungen / Benefits
- flexible and hybrid working options
- minimum 14 weeks paid parental leave
- insurance plans
- retirement plans
- wellbeing resources
- global recognition programs
Verantwortungsbereiche
- Lead the development and lifecycle management of syringe and safety system delivery platforms
- Drive technical innovation to deliver robust, compliant, and patient-centric combination products
- Oversee device design activities and maintain high-quality Design History File documentation
- Define platform strategies that maximise technology reuse while supporting diverse development programmes
- Identify platform-level risks and implement strategic mitigation and continuous improvement plans
- Partner across development, manufacturing, quality, and external organisations to deliver project milestones
- Support regulatory submissions and responses by providing technical expertise for device-related requirements
Zentrale Anforderungen
- Advanced degree in Engineering, Pharmaceutical Sciences, or a related scientific discipline
- Extensive experience developing parenteral drug delivery systems, including prefilled syringes and safety devices
- Strong knowledge of applicable medical device and combination product regulations and standards
- Proven ability to influence cross-functional stakeholders across development, manufacturing, quality, and external partners
- Expertise in technical decision-making, risk assessment, and strategic prioritisation
- Excellent communication skills with fluency in English
- cross-functional collaboration
- strong communication
- influencing stakeholders
- parenteral drug delivery systems
- prefilled syringes and safety devices
- medical device and combination product regulations and standards
Associate Director, Delivery Technology (Syringe and Safety Systems) Arbeitgeber: Novartis
Novartis in Schaftenau, Österreich, ist ein hervorragender Arbeitgeber, der eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf Mitarbeiterentwicklung und kontinuierlichem Lernen fördert das Unternehmen eine Kultur der Zusammenarbeit und Innovation. Die Möglichkeit, an globalen Projekten zu arbeiten und einen bedeutenden Einfluss auf die Gesundheitsversorgung zu haben, macht Novartis zu einem attraktiven Arbeitsplatz für Fachkräfte im Bereich Regulatory Affairs.
