Regulatory Affairs Internship
Why Join Intellia?
Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.
Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.
We want all of our people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.
How you will Achieve More with Intellia:
The Intern, Regulatory Affairs will assist the development and submission of regulatory filings for CRISPR/Cas9- based gene therapy projects, in the US and internationally. You will support the development of innovative global regulatory strategies and the preparation and submission of high‑quality briefing documents, INDs, CTAs, and eventual original marketing applications (BLAs/MAAs), in close collaboration with Regulatory CMC, Nonclinical, Technical Operations and Clinical teams, and external consultants and collaborators, as needed. In this opportunity, your main responsibilities will include:
- As a member of project teams, provide regulatory support for multiple innovative programs
- Proactively identifies regulatory issues for assigned projects; offers creative solutions and strategies, including risk mitigation strategies.
- Manage and implement planning, authoring and submission of high-quality briefing documents and clinical trial applications in the US, EU, Japan and ROW
- With direction from regulatory management, support FDA/global health authority interactions/meetings for project responsibilities; prepare and submit responses to queries
- Drive adherence to global regulatory guidelines relevant for the development of gene therapy products; author, review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
- Partner and work very closely with CMC, Quality, Nonclinical, Clinical and Regulatory CMC to ensure achievement of submission deadlines and obtain timely approvals of clinical trial applications
- Monitor global regulatory guidelines and support interpretation to strengthen product development plan(s) and adopt regulatory strategies in a timely manner
About You:
Do you describe yourself as detailed oriented, collaborative, and enjoy working in a fast-paced, startup environment? If you are currently enrolled in a bachelor’s or master’s degree program in a scientific discipline, we encourage you apply! Our ideal candidate will bring excellent written and communication skills, strong technical knowledge, including regulatory writing. We are also looking for someone with basic working knowledge of drug development process and regulatory requirements in US and EU (Japan, Canada and ROW a plus).
Meet your future team:
The Regulatory Affairs team is a small group of passionate professionals with diverse experience and knowledge, who work closely and collaboratively in developing regulatory strategy, leading regulatory agency interactions and managing regulatory submissions for our innovative products. You will report directly to the Director, Regulatory Affairs. This hiring manager oversees Intellia’s ex vivo programs. Given the breadth of work on this team, the candidate will have the opportunity to explore a wide range of areas within regulatory and the cutting-edge CRISPR technology.
The team is currently working 100% remote. Therefore, we do not require the intern to be local to Cambridge MA. Although in a virtual environment, the team has made it a priority to continue to foster a sense of community among the team. This includes virtual happy hours, team all-hands, open office hours, game nights, and more! You can expect to join a hardworking, collaborative environment. We look forward to fostering your skills, learning from your experiences, and creating a memorable summer internship experience!