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

Internship Opportunity In Regulatory Project Management & Strategic Planning

RPM&SP partners with the global regulatory lead on global regulatory teams to ensure global regulatory project plans for programs 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 under TAK-079 (three indications under R&D for registration consideration) & only one Takeda lead RPM currently managing the asset.

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).

Internship Eligibility :

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 26th-August 14th or June 15th-August 21st).

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.

Takeda does not provide a housing stipend or relocation support for the U.S. summer internship program.

Program Highlights :

Applications will be accepted between November 7th - November 30th.

Takeda Compensation and Benefits Summary :

We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For location : Boston, MA

U.S. hourly wage range :

$21.00 - $46.00

The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year / level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. internship benefits vary by location and may include :

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

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.