2025 Summer Internship Program: Global Regulatory Affairs CMC Intern (takeda)

Job Description

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Job Description

Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise. 

At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond. 

Job Description:

This internship will allow the intern to learn about and engage with 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 to the maintenance of marketed products post health authority approval.
• Working directly with the complexities of regulatory requirements.
• Interacting with leaders involved in the development and execution of strategic plans through product life cycle.

Internship Development Opportunities:

• Gain real-world experience in regulatory submissions and in-depth knowledge about the regulatory complexities surrounding development and marketed products.
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• 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 and require 2-3 days in the Cambridge office per week.
• Basic understanding of computer skills including MS Office (PowerPoint, Words, Excel)
• Internet skills including use of e-mails, group messaging and information gathering
• Highly reliable and a strong team player
• Flexible with an attention to detail
• Strong verbal and written communication skills
• Must be pursuing a Bachelors, Masters, or PhD Degree in a Sciences related field (coursework relating to Regulatory Affairs is 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 2025 or later
• The internship program is 10-12 weeks depending on the two start dates (June 2nd- August 29th) or (June 16th - August 22nd)
  • 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 December 18th and January 10th

For Location:

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.

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Job Exempt