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Senior Manager, Global Labelling Devices
About the role
We are seeking a Senior Manager, Global Labelling Devices to join our Global Regulatory Affairs team within R&D. In this role, you will be responsible for leading the development and implementation of labelling strategies and content for medical devices and combination products, ensuring compliance with global regulatory requirements.
This is a global, cross-functional role where you will partner with stakeholders across Regulatory, Quality, Medical, Safety, Device Development, and Supply Chain, and act as a key contributor to labelling strategy and governance. You will also be responsible for presenting labelling strategies and content to senior leadership and global oversight committees.
Key responsibilities
- Lead end-to-end development and maintenance of Instructions for Use (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 scientific, clinical, or safety 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
Requirements
Education & Experience
- 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
- Demonstrated experience working with combination drug-device products (e.g. pre-filled syringes, auto-injectors)
- Experience with IFU and device labelling content development
- Experience working across both US and EU regulatory environments
- Experience working in a global, matrix environment
Key Skills & Competencies
- Ability to lead cross-functional discussions and drive alignment, not solely contribute technical work
- Strong communication and influencing skills, with confidence presenting to senior stakeholders
- Strong analytical and problem-solving skills with attention to detail
- Ability to manage multiple priorities and deliver high-quality outputs within tight timelines
- Strong collaboration skills across diverse and global teams
Flexible / Preferred Background
We welcome candidates with varied career paths, including those who:
- Have prior medical device experience combined with pharma or regulatory roles
- Have developed experience in combination products at any stage in their career and can connect device and drug regulatory frameworks
Additional Information
- This is a global role requiring close collaboration with US-based stakeholders
- Candidates should be comfortable working in an international environment with some flexibility in working hours
- Role is based in Poland with a hybrid working model (approximately 5 days/month in the office)
What Takeda can offer you
- Opportunity to work at the intersection of pharmaceuticals and medical devices, a rapidly evolving and strategic area
- Exposure to complex global regulatory processes and combination product development
- A collaborative, inclusive, and purpose-driven work environment focused on improving patient outcomes
Inclusion & Diversity
Takeda is committed to creating a diverse and inclusive environment. We encourage applications from all qualified individuals and provide reasonable accommodations for candidates with disabilities throughout the recruitment process.
