Intellia Therapeutics – Global Regulatory Affairs Postdoctoral Research Fellow

Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.

D. graduates. A key element of the program’s success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry. Fellows have the opportunity to work closely with our innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities.

Intellia Therapeutics is a Cambridge-based biotechnology company focused on developing clustered regularly interspaced short palindromic repeats (CRISPR)-based gene editing therapies to transform lives of people with severe diseases. In fact, Intellia’s co-founder Jennifer Doudna along with Emmanuelle Charpentier were awarded the 2020 Nobel Prize in Chemistry for their pioneering work in CRISPR. At Intellia, we are humbled to contribute to what we believe to be medical history.

As a leader in this field, our responsibility and commitment to patients is critical in our pursuit of developing novel, potentially curative therapeutics utilizing CRISPR-based technologies. More specifically, we are employing a modular gene editing platform to create diverse in vivo and ex vivo therapeutics, spanning a range of disease indications. Guided by this full-spectrum approach, we are committed to making CRISPR-based medicines a reality for people living with genetic diseases and to creating novel engineered cell therapies for various cancers and autoimmune diseases.

Northeastern University Pharmaceutical Industry Fellowships Program is a 2-year experiential program designed to advance lifelong learning and the education and training of PharmD graduates. A key element of the program’s success is preparing Fellows to meet evolving workforce needs across various sectors of the pharmaceutical industry. Fellows have the opportunity to work closely with our innovative biopharmaceutical industry partners, while engaging with Northeastern University faculty in professional and career development, teaching, service, and scholarly activities.

In partnership with Northeastern University, Intellia Therapeutics is offering a 2-year Regulatory Strategy and Advertising/Promotion/Labeling (APL) fellowship, based in Cambridge, MA.

The Fellow will collaborate within Global Regulatory Affairs at Intellia, gaining hands‑on experience, contributing to the team, and developing valuable leadership skills. This Regulatory Fellowship is unique in that it offers the opportunity for a blended experience during the first year, encompassing both Strategy and Advertising, Promotion & Labeling. In the second year, the Fellow will have the opportunity to select between the two disciplines, honing skills they developed during the first year and taking a deeper dive into specialized regulatory activities to provide the Fellow with a strong understanding of the drug development and approval landscape, and global regulatory frameworks.

• DEVELOP in-depth knowledge of Intellia’s CRISPR gene editing technology—as well as the pathophysiology, epidemiology, and treatment landscape of relevant therapeutic areas—to support strategic conversations and APL reviews
• BE AN ACTIVE CONTRIBUTOR to the Regulatory team in development of regulatory strategies for assigned projects/products across all phases of product development aimed at achieving marketing authorization and appropriate product labeling
• COLLABORATE with cross-functional…