Regulatory Affairs Specialist

Vor 4 Tagen

Zürich, Zürich, Schweiz Takeda Vollzeit

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Takeda. In this role, you will be responsible for managing end-to-end device and drug-device combination work outsourced by the Global Regulatory Affairs CMC Device and Drug-Device Combinations to external partners.

Key Responsibilities

  • Utilize regulatory strategy and/or 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.
  • Responsible for demonstrating Takeda leadership behaviors and serving 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 and ensure timely communication with line management.
  • Support assigned work on drug-device combination aspects of regulatory submissions in collaboration with sourcing partners.
  • Serve as point of contact for support from sourcing partners on audits and investigations.

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.
  • Solid understanding and proven ability to provide strategy on regulatory requirements relevant to global drug-device combination product development, registration and post-market support.
  • Experience supporting interactions with EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions is strongly preferred.

Travel Requirements

  • Willingness to travel to various meetings or events, including overnight trips. Some international travel may be required.

Location

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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