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

Job Description

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.

Job Summary:

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.

Key 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.

Qualifications:

• The successful candidate will be pursuing a BS/MS degree in the life sciences and be in good academic standing. We are looking for a motivated, self-starter with excellent communication skills and interested in learning about Regulatory CMC.
• Legal authorizationto work in the United States, now and in the future. Please note that Vertex does not provide sponsorship for internships or entry level roles within this part of the organization.
• Candidate must be enrolled in an advanced degree program if graduating before May 2025
• Candidate must be available to work full-time, 40 hours per week from May - August 2025

Pay Range 20.00 - 32.00 USD/hour

This job posting is for a temporary role with a third-party agency partner that provides services to Vertex. The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer. The range provided is a reasonable estimate for the pay range for this job at the time of posting. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. The actual pay rate will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com