Associate Director, Global Regulatory Affairs

4 weeks ago


Étreux, Hauts-de-France, United States Takeda Pharmaceuticals Full time
Job Title: Associate Director, Global Regulatory Affairs

At Takeda Pharmaceuticals, we are seeking an experienced Associate Director to lead our Global Regulatory Affairs team in Cambridge, MA. As a key member of our team, you will be responsible for providing strategic regulatory guidance and oversight for late-stage development projects in multiple indications and device platforms.

Key Responsibilities:

  • Provide global regulatory oversight and execute regulatory activities on late-stage development projects
  • Lead the development of high-level global regulatory strategies and cross-functional submission working groups
  • Collaborate with global regulatory teams to ensure multiple global pre-submission meetings and marketing application submissions
  • Develop and maintain relationships with global health authorities, including FDA, EMA, and PMDA

Requirements:

  • Master's degree in Pharmacy, Biomedical Engineering, Regulatory Affairs, or related field
  • 7+ years of related experience in regulatory affairs, including global health authority interactions
  • Strong knowledge of regulatory requirements and guidelines
  • Excellent communication and leadership skills

What We Offer:

  • Competitive salary: $212,400.00 - $290,400.00 per year
  • Full-time position with up to 20% domestic and international travel
  • Opportunity to work with a global team and contribute to the development of innovative therapies

How to Apply:

Please visit our website at https://jobs.takeda.com and search for Req # R0136180.



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