Global Regulatory Project Management Director

3 weeks ago


Bronx, United States Takeda Pharmaceutical Company Ltd Full time

Takeda is seeking a skilled Director of Global Regulatory Project Management - GI2 to join and lead our Regulatory Affairs team. We are looking for an innovation-driven individual with 10+ years of experience in the pharma industry, with 8 or more of those spent working in regulatory affairs or a related field, and preferably with PMP certification. Candidates for this position should bring strong leadership, decision-making and communication skills to the table, and have the ability to engage, mentor and manage others to maximize their potential.

The successful candidate will be expected to provide expert leadership and guidance to Global Regulatory Teams to ensure effective project management and strategic planning, as well as oversee highly complex cross-functional submission working groups for critical programs. They will work closely with the Global Regulatory Lead (GRL) to support Global Product Team (GPT) regulatory goals, and will be accountable for driving decision making processes and escalating issues as needed. They will also be responsible for generating and delivering reports on major regulatory milestones to key stakeholders across individual programs and the TAU portfolio, as well as supporting the GI2 TAU Regulatory Head in ensuring that regulatory operational support for the therapeutic areas product portfolio is effective, seamless and delivering to expectations.

  • Required qualifications:
  • Advanced degree in a relevant field preferred
  • 10+ years of experience in pharma
  • 8+ years of experience in regulatory affairs or related field
  • PMP certification or equivalent strongly preferred
  • Demonstrated experience leading high performance teams
  • Excellent communication skills, both verbal and written
  • Strong teamwork and collaboration abilities
  • Sharp decision-making and problem-solving abilities

Learn more about this exciting opportunity by applying


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