Regulatory Affairs Specialist

vor 4 Wochen


Zürich, Zürich, Schweiz Takeda Vollzeit

Job Summary

Takeda is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for device and drug-device combination products.

Key Responsibilities

  • Develop and implement regulatory strategies for device and drug-device combination products
  • Ensure compliance with regulatory requirements for device and drug-device combination products
  • Collaborate with cross-functional teams to ensure regulatory requirements are met
  • Provide regulatory guidance and support to internal stakeholders
  • Stay up-to-date with regulatory changes and developments

Requirements

  • 8+ years of pharmaceutical Regulatory CMC and Medical Device experience
  • 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
  • Demonstrates emerging leadership, problem-solving ability, flexibility and teamwork
  • Excellent written and oral communication skills

What We Offer

  • Opportunity to work with a global leader in the pharmaceutical industry
  • Collaborative and dynamic work environment
  • Competitive salary and benefits package
  • Opportunities for professional growth and development

Location

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time



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