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Sr Manager, Global Labeling Devices at Takeda Pharmaceutical Company Limited - ApplyBlast

Sr Manager, Global Labeling Devices

Takeda Pharmaceutical Company Limited

3 months ago

Lodz, Poland

Hybrid

Full Time

Senior

0 applicants

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About this role

A Senior Manager for Global Labelling Devices leads the development and implementation of labelling strategies for medical devices and combination products within the Global Regulatory Affairs team. The role involves cross-functional collaboration across Regulatory, Quality, Medical, and Supply Chain stakeholders to ensure global compliance with US and EU regulatory requirements. Candidates must present strategies to senior leadership and manage labelling submissions while addressing risks in a matrixed global environment.

Responsibilities

Lead end-to-end development of device labelling content and instructions for use
Drive cross-functional collaboration to align labelling strategy with regulatory compliance
Develop labelling strategies for combination drug-device and standalone medical products
Present labelling recommendations and risks to senior leadership and governance forums
Manage labelling submissions and implementation of safety or clinical data updates

Skills

Qualifications

Bachelor's degree in a scientific disciplineExperience in regulatory affairs or labelling within pharmaceutical or medical device industriesExperience working with combination drug-device productsExperience with IFU and device labelling content developmentExperience working across US and EU regulatory environments