Global Device Labelling Strategy Lead

Takeda; Łódź; Hybrid; PLN 267,000 - 368,000; Full time

Job summary

Takeda in Lodz, Poland, seeks a Senior Manager, Global Labelling Devices to lead development and implementation of labelling strategies for medical devices and combination products. You will partner with Regulatory, Quality, Medical, Safety, Device Development, and Supply Chain to drive alignment and governance globally.

The role requires significant regulatory/R&D experience, with focus on US and EU requirements, and ability to influence senior leadership.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Significant experience in regulatory affairs and/or labelling within pharmaceutical and/or medical device industries.
• Experience with IFU and device labelling content development.
• Experience working across US and EU regulatory environments.
• Experience working in a global, matrix environment.

Responsibilities

• Lead end-to-end development and maintenance of IFU and device labelling content.
• Drive cross-functional collaboration to align labelling strategy and ensure regulatory compliance.
• Develop labelling strategies for combination drug/device products and standalone devices.
• Lead and facilitate labelling working groups and drive decision-making across global stakeholders.
• Present labelling recommendations, risks, and strategies to senior leadership and governance forums.
• Ensure labelling content complies with US and EU regulatory requirements and aligns with global regulatory strategy.
• Support labelling submissions, updates, and implementation of new data.
• Partner with local affiliates to ensure alignment with global labelling and manage exceptions where required.
• Proactively identify risks and propose mitigation strategies related to labelling content and implementation.

Skills

Cross-functional leadership

Regulatory affairs

Regulatory strategy

Communication

Attention to detail

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Takeda in Lodz, Poland, seeks a Senior Manager, Global Labelling Devices to lead development and implementation of labelling strategies for medical devices and combination products. You will partner with Regulatory, Quality, Medical, Safety, Device Development, and Supply Chain to drive alignment and governance globally.

The role requires significant regulatory/R&D experience, with focus on US and EU requirements, and ability to influence senior leadership.