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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).
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:
Hands-on experience with real projects and responsibilities
Dedicated mentorship program pairing interns with experienced professionals
Networking opportunities with industry professionals and fellow interns
Internship events focused on professional and skills development
Exposure to multiple business areas or departments within a Pharmaceutical Organization
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, MAU.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:
Paid sick time
Civic Duty paid time off
Participation at company volunteer events
Participation at company sponsored special events
Access to on-site fitness center (where available)
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.
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.
Job Exempt
NoIt 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.