Regulatory Affairs Director

3 days ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time
Job Title: Associate Director, Global Regulatory Affairs

At Takeda Pharmaceutical, we are seeking an experienced Associate Director, Global Regulatory Affairs to join our team in Cambridge, MA.

Job Summary:

We are looking for a highly skilled and motivated individual to lead our global regulatory strategy and ensure compliance with regulatory requirements. The successful candidate will have a strong background in regulatory affairs, with experience in leading global projects and interacting with health authorities.

Key Responsibilities:

  • Develop and implement global regulatory strategies for late-stage development projects
  • Provide regulatory oversight and execute regulatory activities for multiple indications and device platforms
  • Lead global health authority interactions, including preparation meetings with FDA, EMA, and other regulatory bodies
  • Develop high-level global regulatory supplemental biologic application (sBLA) strategy and lead global cross-functional submission working groups
  • Collaborate with global regulatory teams to ensure multiple global pre-submission meetings and marketing application submissions

Requirements:

  • Master's degree in Pharmacy, Biomedical Engineering, Regulatory Affairs, or related field
  • 7+ years of related experience in regulatory affairs, with a strong background in immunology and inflammation therapeutic franchise
  • Proven experience in leading global projects and interacting with health authorities
  • Strong communication and leadership skills

What We Offer:

  • Competitive salary and benefits package
  • Opportunity to work with a global pharmaceutical company
  • Collaborative and dynamic work environment

How to Apply:

Apply online at [insert link] and search for Req # [insert number].



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