Global Regulatory Affairs Director

24 hours ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time
Takeda Pharmaceutical Job Opportunity

We are seeking an experienced professional to join our team as an Associate Director, Global Regulatory Affairs. This role will be based in Cambridge, MA and will involve working on late-stage development projects in multiple indications, device platforms, and cell line changes.

Key Responsibilities:
  • Provide global regulatory oversight and execute regulatory activities on late-stage development projects.
  • Lead the development of high-level global regulatory supplemental biologic application sBLA strategy.
  • Collaborate with global regulatory teams to ensure multiple global pre-submission meetings and marketing application submissions.
  • Develop and implement global regulatory strategies to ensure compliance with health authority regulations.
  • Lead global submission strategy across multiple respiratory indications.
Requirements:
  • Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs, or related field.
  • 7 years of related experience, including prior experience as a Global and US Regulatory Strategic Lead (GRL).
  • Global experience of health authority interactions, including preparation meetings with FDA, EMA, BRDD, and PMDA.
  • Up to 20% domestic and international travel required.
Benefits:
  • Competitive salary range: $212,400.00 - $290,400.00 per year.
  • Full-time position.

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