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Regulatory Therapeutic Area Team Lead

vor 2 Monaten


Zürich, Zürich, Schweiz Takeda Pharmaceuticals International AG Vollzeit

Job Summary

Takeda Pharmaceuticals International AG is seeking a highly experienced Regulatory Therapeutic Area Team Lead to oversee and direct all regulatory activities related to oncology products in the Europe & Canada region.

Key Responsibilities

  • Provide strategic leadership and oversight to a team of regulatory strategists who define, develop, and lead Europe & Canada (EUCAN) regulatory strategies to maximize regulatory success and strengthen the product development plan in support of enabling patient access.
  • Ensure recruitment, line management, and development of direct reports; provide direction, support, mentoring, and strategic guidance to fulfill the scope of project work.
  • Provide strategic and tactical advice and guidance and regional regulatory expertise to regional and global leadership teams on how to achieve timely and efficient conduct of all development and/or life-cycle management programs pertaining to oncology, while maintaining full compliance with applicable regulatory requirements.
  • Ensure team resourcing and appointment of appropriately skilled EUCAN Regulatory Leads to Global Regulatory Teams and Submission Working Groups.
  • Manage or support and oversee health authorities interactions in the region and key external stakeholder management.

Requirements

  • BSc. Advanced scientific related degree preferred.
  • A minimum of 15 years of regulatory affairs experience in the pharmaceutical/biotechnology industry within the EU region.
  • Comprehensive knowledge of regional regulatory requirements and guidelines for oncology products.
  • Proven track record of successful regulatory submissions and approvals for oncology products.
  • Experience with advanced therapeutic medical products (Cell & gene therapy) will be advantageous.
  • Solid regulatory experience, including knowledge of regulations and guidance applicable in the region governing drugs and biologics in all phases of development.
  • Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively.

What We Offer

Takeda Pharmaceuticals International AG is a global top employer that offers exciting career paths, promotes innovation, and strives for top performance in everything we do. We foster an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.