Regulatory Affairs

Co-Op Assignment Overview

Prime Medicine is seeking a co-op for the Fall 2025 semester with experience and/or knowledge in natural science such as Biology, Chemistry or other biotech-related disciplines to join the Regulatory Affairs team. The Prime Medicine Regulatory Affairs team is a tight-knit, closely collaborative, highly creative group working to make the promise of Prime Editing a reality for patients with severe genetic diseases.  The qualified candidate will be highly motivated, analytical and collegial.  The candidate will support the Regulatory Affairs team in ensuring compliance with relevant regulations and guidelines relevant to the company's gene editing pipeline programs for patients with genetic diseases. You will assist in researching, interpreting, and implementing regulatory requirements, as well as providing administrative support for regulatory submissions and documentation.

Primary Responsibilities:

• Conduct research on regulatory requirements pertinent to the company's product pipeline. Stay updated on changes in regulations and guidelines affecting the industry.
• Assist in maintaining regulatory documentation, spreadsheets, and trackers related to the compilation of required inputs for regulatory submissions. Ensure all documents and trackers are organized and up to date.
• Support the preparation, compilation, and submission of regulatory documents to FDA and ex-US regulatory agencies. This may include applications for regulatory agency meetings, drug designations, and/or investigational new drug applications.
• Assist in monitoring compliance of clinical-stage development programs with regulatory requirements and adherence to regulations.
• Cross-functional collaboration with other departments, such as R&D, preclinical, and clinical teams to gather information and help ensure regulatory compliance in product development, testing, and regulatory submission packages.
• Assist in preparing regulatory reports and responses to regulatory inquiries.
• Participate in training sessions and educational programs to enhance understanding of regulatory requirements and processes.
• Undertake additional ad-hoc tasks and projects as assigned by the Regulatory Affairs team to support departmental objectives and business needs.

Qualifications:

• Currently enrolled in a Bachelor's or Master's degree program in a relevant field such as Regulatory Affairs, Life Sciences, Pharmacy, Biology, or a related discipline.
• Strong attention to detail and organizational skills.
• Excellent analytical, written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Proficiency in Microsoft Office suite (Word, Excel, PowerPoint).

Preferred Qualifications (but not required):

• Prior experience, course work, and/or certification in regulatory affairs.
• Familiarity with medical terminology.
• Basic understanding of cellular and molecular biology underlying gene therapy.
• Familiarity with document management systems and spreadsheets (Smartsheet, Excel, etc.).

What We Offer:

• A cutting-edge scientific team open to mentorship and networking.
• Full reimbursement for monthly commuting costs including MBTA, Commuter Rail, or Bluebikes, etc.
• Participation in regular scientific seminars with industry experts.
• Full participation in employee activities including learning and development offerings, social activities, etc.

NOTE: We are currently not considering co-op candidates outside of the local Boston/Cambridge area.