2026 Summer Internship Program: Regulatory Project Manager Intern for the Global Regulatory Project Management & Strategic Planning (RPM&SP) - GI Therapeutic Area

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Job Description

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

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.

Internship Development Opportunities:

The intern will gain hands-on exposure to the regulatory strategy and operations function within Takeda’s GI therapeutic area, Specifically TAK-079 (three indications under development). By supporting health authority meeting preparation and submission planning, the intern will learn how cross-functional teams collaborate to advance innovative therapies through regulatory milestones. This role provides practical project management and regulatory operations experience that builds a strong foundation for a career in global drug development.

Job Requirements:

• This position will be Fully Remote

• 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).

For Location:

Boston, MA

U.S. Hourly Wage Range:

$21.00 - $46.00

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Paid Intern (Fixed Term) (Trainee)

Time Type

Full time

Job Exempt

No

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