About The Position

RPM&SP partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals. Oversees and provides regulatory operational support for programs in the Therapeutic Area Unit (TAU). Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning . The intern will support the Gastrointestinal (GI) Global Regulatory Project Management & Strategic Planning (RPM&SP) group in advancing regulatory milestones. This role will provide hands-on experience in health authority meeting planning, developing submission timelines, and supporting scenario planning for key regulatory deliverables. How You Will Contribute: The RPM&SP intern will provide valuable support in developing timelines, scenario analyses, and health authority meeting logistics—activities that directly impact the group’s ability to meet regulatory milestones efficiently. The intern contribution will help in assisting the lead RPM to focus on strategy while ensuring operational excellence. In addition, the intern’s fresh perspective and analytical work will enhance the team’s ability to anticipate challenges and optimize submission planning

Requirements

  • Currently pursuing a Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Pharmacy, or related field.
  • Strong organizational, analytical, and communication skills.
  • Interest in regulatory strategy, drug development, and project management.
  • Proficiency with Microsoft Office (Excel, PowerPoint, Project/Timeline tools a plus).
  • Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship
  • Must be currently enrolled in a degree program graduating December 2026 or later
  • The internship program is 10-12 weeks depending on the two start dates (May 26 th -August 14 th or June 15 th - August 21 st )
  • The intern must be able to commit to one of these time frames
  • Able to work full time 40 hours a week during internship dates

Responsibilities

  • Assist in planning and logistics for health authority (HA) meetings, including preparation of timelines, coordination of materials, and tracking key actions.
  • Support the development of submission timelines and scenario analyses to evaluate regulatory strategy options.
  • Contribute to the preparation of regulatory documentation and project tracking tools.

Benefits

  • Paid sick time
  • Civic Duty paid time off
  • Participation at company volunteer events
  • Participation at company sponsored special events
  • Access to on-site f itness c enter (where a vailable )
  • Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.
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