Director of Regulatory Excellence

Vor 2 Tagen


Stäfa, Zürich, Schweiz Takeda Vollzeit
Regulatory Affairs Director Job Summary

We are looking for an experienced Regulatory Affairs Director to join our team in Zurich, Switzerland. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing regional regulatory strategies to support the approval and commercialization of our products.

Key Responsibilities
  • Develop Regulatory Strategies: Collaborate with cross-functional teams to develop and implement regional regulatory strategies that align with business objectives.
  • Manage Regulatory Submissions: Oversee and manage regional regulatory submissions, ensuring timely approvals throughout product development and lifecycle.
  • Provide Regulatory Expertise: Offer strategic advice on emerging trends, regulations, and changes, and provide regulatory expertise on drug development, registration, and post-marketing compliance.
  • Represent Takeda: Represent the company in Health Authority meetings and negotiations, effectively communicating and managing meeting outcomes and next steps.
Requirements
  • Education: BSc or BA degree in a scientific field, preferably with experience in drug regulatory affairs.
  • Experience: A minimum of 8 years of experience in drug regulatory affairs, preferably within the EU/GEM region.
  • Regulatory Knowledge: Solid understanding of regulations and guidance applicable in the region, across all phases of development.
  • Communication Skills: Effective communication skills, including the ability to present complex scientific information in a clear and concise manner.


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