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We are looking for a
to lead strategic and operational CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management. In this role, you will shape global CMC regulatory strategy, ensure compliant execution of submissions and changes, and partner with technical and regulatory teams worldwide.
Key Responsibilities:
Responsible for operational CMC regulatory activities related to the assigned products and/or intermediates, including as applicable:
Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g. MAAs, BLAs) and life cycle submissions according to agreed timelines and taking regional regulatory requirements into account. This may include technical authoring of dossier narratives and other regulatory CMC documentation.
Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g. CMC documentation for Scientific Advice Meetings, Briefing Books, IBs).
Preparation and review of CMC related information and documentation required for tenders, PSURs, DSURs, CCDS/product information and promotional materials.
Responsible for strategic CMC regulatory activities related to the assigned products and/or intermediates, including as applicable:
Is responsible for development and implementation of global CMC regulatory strategies for product development, clinical trial applications, new license applications, product changes and relevant CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements.
Qualification:
Basic knowledge of the regulatory framework in at least one key region (US, EU, Japan, CH, Australia).
Competencies
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.