2026 U.S Summer Internship Program: Global Regulatory Affairs CMC Intern

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Job Description

The Global Regulatory Affairs, Chemistry, Manufacturing, and Controls (GRA CMC) team resides within Takeda’s R&D organization. We are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing our R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.

In an ever-changing and increasingly complex regulatory environment, we partner to develop and execute innovative CMC regulatory strategies to provide high-quality medicines and technologies to patients throughout the product lifecycle.

This internship will allow the intern to learn about various Regulatory CMC functions (including but not limited to Small Molecules, Biologics, Devices & Combination Products, Conformance and Submission Excellence) involved in the development of new products through the maintenance of marketed products post health authority approval. In particular, the intern will gain valuable experience of the complexities of regulatory requirements. The intern will be interacting with leaders involved in the development and execution of strategic plans through product life cycle.

How You Will Contribute:

• Exceptional interpersonal, verbal communication and writing skills.

• Deadline-driven with an elevated level of organizational and planning skills.

• Strong quantitative, analytical, problem solving and conceptual skills.

• Proven record of accomplishment of teamwork, adaptability, innovation, initiative, and integrity.

• Global mindset to grow in a diverse work environment.

• Creative thinking – able to develop innovative solutions and think creatively.

• Computer literacy and data management skills.

• Project planning and Task management skills.

Internship Development Opportunities:

• Gain real-world experience in regulatory submissions and in-depth knowledge about the regulatory complexities surrounding development and marketed products.

• Learn about CMC business process and process excellence and systems and their role in development of new products and maintenance of marketed products post approval.

• Exposure from a regulatory CMC perspective to the development process of small molecules, biologics and combination products.

• Collaborate with various teams within GRA CMC and across different functions, gaining various insights from industry leaders, honing interpersonal and communication skills and building valuable professional connections.
   

Job Requirements:

• This position will be Hybrid (1-3 days/week in office) out of the Cambridge, MA & Lexington, MA location.

• Must be pursuing a Masters, and/or Doctoral Degree in Chemistry, Pharmaceutical Sciences, Regulatory Affairs, Biochemistry, Life Sciences, or related fields..

• Available to work full-time (40 hours per week), within the core business hours of 8:00am – 5:00pm, for 11-12 weeks during the summer months.

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 

• Int