Senior Regulatory Specialist, Device and Drug-Device Combinations EU and Global Markets

Vor 7 Tagen

Zürich, Zürich, Schweiz Takeda Vollzeit

About the Role

Takeda is seeking a highly skilled and experienced Regulatory Affairs professional to join our team as a Senior Regulatory Specialist, Device and Drug-Device Combinations EU and Global Markets. In this role, you will be responsible for developing and implementing innovative regulatory strategies for drug-device combination products in EU and Global Markets.

Key Responsibilities

  • Develop and implement regulatory strategies for drug-device combination products in EU and Global Markets
  • Collaborate with cross-functional teams to ensure regulatory compliance and effective change management
  • Build and maintain strong relationships with key stakeholders, including regulatory authorities and internal teams
  • Provide regulatory guidance and support to product teams, ensuring alignment with EU and Global Markets regulatory strategies
  • Identify and mitigate regulatory risks, ensuring timely communication with line management

Requirements

  • 8+ years of pharmaceutical Regulatory CMC and Medical Device experience, including experience as a regulatory representative for drug-device combination products in EU and Global Markets
  • 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
  • Excellent written and oral communication skills, with cross-organization stakeholder engagement

What We Offer

  • Opportunity to work with a world-class R&D organization
  • Collaborative and dynamic work environment
  • Competitive compensation and benefits package

Location

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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