Manager Labeling & Regulatory Projects (f/m/x)

Trust something new, grow beyond itself and redefine the boundaries of the feasible. That is exactly what our employees can and should live daily. To set the pace with our innovations and make it great. Because there are a lot of fascinating people behind every successful company. ZEISS employees work in an open and modern environment with numerous development and further training opportunities. Our culture is characterized by expert knowledge and team spirit. All this is supported by the special ownership structure and the long-term goal of the Carl-Zeiss Foundation: to advance science and society together.

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Diversity is part of ZEISS. We look forward to your application regardless of gender, nationality, ethnic and social origin, religion, world view, disability, age as well as sexual orientation and identity.

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Developing and consistent implementation of global labeling strategy in international markets

Ensuring regulatory compliance of all labeling elements according to global and local requirements

Independent analysis of international regulatory labelling requirements and transfer to specific product solutions

Responsibility for the timely creation, release and implementation of labeling elements (Labels, IFUs, Packaging etc.)

Independent planning and structuring of the labeling work package including scope, timelines, technical details and resource requirements

Definition of work packages, coordination with relevant interfaces (SSC, RA, R&D, LCM etc.), creation of loadable project plans and acquisition of project release

Management and coordination of complex labeling projects up to successful approval

Transparent status and progress reports on milestones, risks and results

Preparation and submission of documents to authorities and registration bodies – directly or via SSCs or Distributors

Support in preparing negotiations with international authorities and registration bodies

Self-cooperation with SSCs and internal interfaces for obtaining and maintaining authorisations

Process Responsibility & Continuous Improvement Responsibility for the further development of global and local labelling processes (e.g. LAB SOPs, Print-on-Demand)

Active co-design and optimization of associated tools and systems (e.g. Polarion)

Analysis of the existing process landscape and identification of optimization potentials

Implementation of shared improvement measures at global or local level

Close communication and cooperation with local and global departments (e.g. QM, RA, LCM) to improve efficiency

Conception and implementation of training on labeling processes, tools and regulatory requirements

Your profile Multiannual experience in Regulatory Affairs, Labeling or the regulated project environment

Funded project management competence with clear structuring and implementation strength

Deep understanding of international regulatory requirements

High self-responsibility, decision strength and solution orientation

Impressed communication skills in an international environment

German and English skills