Vertex Summer 2025 Intern, Regulatory Affairs CMC (Boston, MA)

Vertex Pharmaceuticals • Boston, MA

276d • $20 - $32

About The Position

The Vertex Internship Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our internship program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and 'we are relentless' is in everything we do. Students can expect to be challenged by their project plan, connect with other interns, and feel valued by the Vertex community. Not only will interns learn about their day-to-day tasks through their specific work assignments, but they will interact and have exposure to our organizational leaders and their teams. The Chemistry Manufacturing Controls (CMC) Regulatory Affairs intern will have an opportunity to contribute to and be exposed to the preparation and review of regulatory submissions to support Vertex's pipeline of medicines. Experienced gained in this role may include (but not limited to): gain knowledge of CMC content in IND, NDA/BLA, and other global submissions, introduction to regulatory and industry guidances, and an understanding of the collaborative role of the CMC regulatory professional. The intern may also maintain or improve internal dashboards and tracking tools or support other department initiatives, gather information for drafting regulatory submission deliverables, and provide entry-level writing support for routine submissions. This intern role is a great opportunity for someone completing a B.S. or M.S. degree in science-related field with an interest in the drug development process. The successful candidate will have exposure to the lifecycle activities of different Vertex compounds.

Requirements

• Pursuing a BS/MS degree in the life sciences
• In good academic standing
• Motivated, self-starter with excellent communication skills
• Interest in learning about Regulatory CMC
• Legal authorization to work in the United States, now and in the future
• Must be enrolled in an advanced degree program if graduating before May 2025
• Must be available to work full-time, 40 hours per week from May - August 2025

Responsibilities

• Support Regulatory submissions
• Interact with Regulatory CMC professionals within Vertex team as well as Quality Assurance, and international regulatory leads, as appropriate.
• Support cross functional meetings that include technical stakeholders, example: prepare meeting minutes, with support from Reg CMC lead, support document revisions, etc.
• Collaborate with Regulatory Affairs stakeholders to drive document through to submission-ready.
• Support document management and upload to the Regulatory Information Management (RIM) system.

Benefits

• Medical, dental and vision benefits
• Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• Educational assistance programs including student loan repayment
• Generous commuting subsidy
• Matching charitable donations
• 401(k)
• Annual bonus and annual equity awards
• Overtime pay eligibility in accordance with federal and state requirements

What This Job Offers

• Job Type: Full-time
• Career Level: Intern
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree