Regulatory Affairs Co-op

PepGen • Boston, MA

10d • $30 • Onsite

About The Position

The Co-op will support key aspects of regulatory to support the development of PepGen’s clinical stage novel peptide-oligonucleotide conjugate therapeutics for a range of neuromuscular and neurologic indications. In this hands-on regulatory position, the successful candidate will work closely with the Global Regulatory and Medical Writing team and gain exposure and experience in how to develop a global regulatory strategy, including submissions, regulatory compliance, and the understanding and application of guidance and requirements for multiple geographies (including the USA and Canada, and beyond).

Requirements

• Must be an active Northeastern University student pursuing a BS or MS in Biology, Pharmaceutical Sciences, or a closely related field.
• Must have excellent interpersonal, written and verbal communication skills, and administrative skills
• Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
• Ability to work onsite Tuesday – Thursday from 9am to 5pm in the Boston office during the Fall Co-op Cycle (July-Dec 2026)

Responsibilities

• With the wider teams, develop planning, logistics, and document development for regulatory agency submissions and interactions including CTA submissions, development of query responses documents, briefing documents for agency interactions and other general regulatory agency submissions
• Support Regulatory Intelligence surveillance and interpretation to aid the development of the global regulatory strategy plans to anticipate regulatory obstacles and emerging issues, including changing regulations
• Support the development of regulatory processes for submission planning and management, and oversight of regulatory requirements.

Benefits

• PepGen provides co-op employees with paid federal holidays, sick time, and a fully subsidized MBTA pass.

What This Job Offers

• Career Level: Intern
• Number of Employees: 51-100 employees