Global Regulatory Strategist for Device and Combination Products
vor 7 Stunden
This Full-time position is now available as a Global Regulatory Strategist for Device and Combination Products at Takeda.
Job DescriptionThe successful candidate will be responsible for leading the end-to-end management of device and drug-device combination work outsourced by the Global Regulatory Affairs CMC Device and Drug-Device Combinations to external partners. This includes liaising, coordinating, and providing oversight to ensure compliance with regulatory requirements.
In this role, you will utilize your knowledge of regulatory strategy and operational expertise to shape global regulatory best practices, drive internal consistency, and influence effective change management.
You will build and manage strong working relationships through active partnering with key internal and external stakeholders, including sourcing partners, regulatory authorities, and other cross-functional teams.
Key Responsibilities- Demonstrate Takeda leadership behaviors and serve as the primary contact for sourcing partners on select programs and cross-program work.
- Identify combination product and device-related regulatory risks and communicate them to line management in a timely manner.
- Support assigned work on drug-device combination aspects of regulatory submissions, including CTAs, registrations, variations, technical files, notified body opinions, CE marking, and other relevant documents.
- Serve as the point of contact for support from sourcing partners on audits and investigations.
To be successful in this role, you will need:
- A BS/BA degree in a scientific, pharmaceutical, or engineering discipline.
- 8+ years of pharmaceutical regulatory CMC and medical device experience, including experience as a regulatory representative for drug-device combination products.
- Experience working on cross-functional submission teams and supporting interactions with EMA, Notified Bodies, and other global health authorities.
- Emerging leadership skills, problem-solving ability, flexibility, and teamwork experience.
- Excellent written and oral communication skills, with the ability to engage with cross-organization stakeholders.
This role offers a competitive salary range of $120,000 - $180,000 per year, depending on experience, plus additional benefits, including:
- A comprehensive health insurance package.
- A retirement savings plan with employer matching.
- Generous paid time off and holidays.
- A flexible work arrangement policy, including remote work options.
This position is currently based in Zurich, Switzerland, with approximately 10% travel required for meetings and events.
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