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Global Regulatory Affairs Director

1 month ago

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

We are seeking an experienced Associate Director, Global Regulatory Affairs to join our team at Takeda Development Center Americas, Inc. in Cambridge, MA.

Key Responsibilities:

  • Provide global regulatory oversight and execute regulatory activities on late-stage development in multiple indications, device platforms, and cell line changes.
  • Lead the development of high-level global regulatory supplemental biologic application sBLA strategy and the KO of global cross-functional submission working group.
  • Lead global submission strategy across multiple respiratory indications and work with global regulatory team to ensure multiple global pre-submission meetings and marketing application submissions.
  • Collaborate with cross-functional teams to ensure regulatory compliance and provide guidance on regulatory strategies.
  • Develop and maintain relationships with health authorities, including preparation meetings with FDA, EMA, BRDD, and PMDA.

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.

What We Offer:

  • Competitive salary range: $212,400.00 - $290,400.00 per year.
  • Full-time position.
  • Opportunity to work with a global pharmaceutical company.

How to Apply:

Apply online at https://jobs.takeda.com and search for Req # R0136180.