Senior Regulatory Strategist for Device and Drug-Device Combinations

Vor 4 Tagen

Zürich, Zürich, Schweiz Takeda Vollzeit

Unlock Innovation in Medical Devices

Takeda is a leading R&D organization that pushes the boundaries of what's possible to bring life-changing therapies to patients worldwide.

We are seeking a seasoned Senior Regulatory Strategist to join our team in Zurich, Switzerland. As a key member of our Global Regulatory Affairs CMC Device and Drug-Device Combinations team, you will play a critical role in shaping global regulatory best practices and driving effective change management.

About the Role:

  • Lead 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.
  • Utilize regulatory strategy and operational expertise to shape global regulatory best practices and drive internal consistency.
  • Build and manage strong working relationships through active partnering with key internal and external stakeholders.

Responsibilities:

  • Demonstrate Takeda leadership behaviors and serve as primary Global Regulatory Affairs CMC Device and Drug-Device Combinations contact for sourcing partners on select programs and cross-program work.
  • Proactively identify combination product and device-related regulatory risks, ensuring timely communication with line management.
  • Support assigned work on drug-device combination aspects of regulatory submissions (e.g., CTAs, registrations, Variations, Technical Files, Notified Body Opinions, CE marking, etc.) in collaboration with sourcing partners.

Requirements:

  • 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.

What We Offer:

  • A competitive salary of approximately €110,000 per year, based on your qualifications and experience.
  • The opportunity to work on cutting-edge medical devices and contribute to the development of innovative therapies.
  • A collaborative and dynamic work environment with a talented team of professionals.
  • A hybrid work arrangement, allowing for flexibility and work-life balance.

Travel Requirements:

  • Approximately 10% travel, including overnight trips and some international travel may be required.

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