Intellia Therapeutics – Global Regulatory Affairs Postdoctoral Research Fellow

Northeastern University•Boston, MA

1d•$60,315 - $85,193•Hybrid

About The Position

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. In partnership with Northeastern University, Intellia Therapeutics is offering a two-year Regulatory Affairs PharmD fellowship based in Cambridge, MA. 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. Intellia Regulatory Affairs Fellowship Program Overview: 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.

Requirements

Doctor of Pharmacy (PharmD) degree from an ACPE-accredited institution
Eligible for pharmacist licensure in the State of Massachusetts
Excellent oral and written communication skills
Strong scientific acumen, ability to understand complex scientific data, and an interest in gene editing and CRISPR
Strong time management and leadership abilities
Ability to work independently and take initiative on a variety of projects at both Intellia and Northeastern University
Capability to be onsite at Intellia to meet with fellows and others based on team/project needs, as well as onsite Regulatory meetings quarterly
Ability to travel to scientific conferences in the US

Nice To Haves

Electives related to Regulatory Affairs a plus

Responsibilities

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 stakeholders on the development and execution of medical communications, marketing materials, and regulatory filings and correspondence
ASSIST in planning and coordinating regulatory submissions necessary to support clinical trials, product registrations, post marketing requirements and commitments, and product-claim promotional materials
SUPPORT development and preparation of annual reports, amendments, supplements, and other activities for investigational new drugs (INDs) and biologic license applications (BLAs)
PREPARE for regulatory agency meetings, including meeting plan, development of briefing books, and ensuring submitted documents are high quality and compliant
COLLABORATE with Regulatory Operations team members to establish and meet timelines for regulatory submissions
LEAD THE DEVELOPMENT of a method for researching and communicating changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictions
NETWORK across Regulatory, Medical Writing, Program Teams, Medical Affairs, Corporate Communications, and the Commercial organization to gain a thorough understanding of industry opportunities and expand upon experiences by developing and completing several projects of interest
DEVELOP KNOWLEDGE IN PREPARATION TO LEAD review and approval of Medical and Commercial tactics in support of product launch and other initiatives
COLLABORATE with internal teams and vendors to prepare for inspections and audits
FOSTER COLLABORATION AND LEADERSHIP SKILLS through cross-functional projects and present information of interest to the Regulatory team and to Medical, Legal, Regulatory (MLR) committees
PARTICIPATE in fellowship recruitment activities and interviews