Co-op: Regulatory Affairs
Prime Medicine is seeking a co-op for the Fall 2026 semester to join the Regulatory Affairs team. This team is dedicated to ensuring compliance with relevant regulations and guidelines for the company's gene editing pipeline programs targeting severe genetic diseases. The co-op will play a crucial role in supporting the team by researching, interpreting, and implementing regulatory requirements, as well as assisting with administrative tasks related to regulatory submissions and documentation.
Key responsibilities include conducting research on regulatory requirements pertinent to the company's product pipeline and staying updated on changes in industry regulations and guidelines. The co-op will assist in maintaining regulatory documentation, spreadsheets, and trackers, ensuring all documents are organized and current. Additionally, the role involves supporting the preparation, compilation, and submission of regulatory documents to FDA and international regulatory agencies, which may include applications for regulatory agency meetings, drug designations, and investigational new drug applications.
The ideal candidate is currently enrolled in a Bachelor's or Master's degree program in a relevant field such as Regulatory Affairs, Life Sciences, Pharmacy, or Biology. Strong attention to detail and organizational skills are essential, along with excellent analytical, written, and verbal communication abilities. The candidate should be proficient in Microsoft Office suite (Word, Excel, PowerPoint) and capable of working both independently and collaboratively in a team environment. Preferred qualifications include prior experience or coursework in regulatory affairs, familiarity with medical terminology, a basic understanding of cellular and molecular biology underlying gene therapy, and experience with document management systems and spreadsheets.
The compensation for this co-op position ranges from $23 to $33 per hour. This role offers a unique opportunity to gain hands-on experience in regulatory affairs within a leading biotechnology company focused on innovative gene editing therapies. The co-op will have the chance to work closely with experienced professionals, participate in training sessions, and contribute to projects that have a meaningful impact on patients with genetic diseases.