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Regulatory Affairs Manager

2 months ago

Cambridge, Cambridgeshire, United Kingdom Takeda Pharmaceutical Full time
Job Title: Regulatory Affairs Manager

At Takeda, we are a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide.

We are seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Global Regulatory Affairs CMC Device and Drug-Device Combinations team, you will be responsible for end-to-end management, including liaising, coordinating, and providing oversight for device and drug-device combination work outsourced by the Global Regulatory Affairs CMC Device and Drug-Device Combinations to external partners.

You will utilize regulatory strategy and/or operational expertise and lessons learned to shape global regulatory best practices, drive internal consistency, and influence effective change management.

As the primary Global Regulatory Affairs CMC Device and Drug-Device Combinations contact for sourcing partners on select programs and cross-program work, you will proactively identify combination product and device-related regulatory risks, ensuring timely communication with line management.

Key Responsibilities:

  • Liaise with external partners to ensure compliance with regulatory requirements
  • Develop and implement regulatory strategies to drive global consistency
  • Provide oversight and guidance on device and drug-device combination work
  • Identify and communicate regulatory risks to line management
  • Support regulatory submissions, including drug-device combination aspects

Requirements:

  • BS/BA Degree in a Scientific, Pharmaceutical, or Engineering Discipline
  • 8+ years of pharmaceutical Regulatory CMC and Medical Device experience
  • Experience as a regulatory representative for drug-device combination products
  • Solid understanding of regulatory requirements relevant to global drug-device combination product development, registration, and post-market support

Takeda is an equal opportunities employer and welcomes applications from diverse candidates. We offer a competitive compensation package and a dynamic work environment.