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. Role Overview: 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 under TAK-079 (three indications under R&D for registration consideration) & only one Takeda lead RPM currently managing the asset. 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 TAK-079 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
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Job Type
Full-time
Career Level
Intern
Number of Employees
5,001-10,000 employees