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Regulatory:
Regulatory Operations Associate

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.   

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:

As an Associate joining our growing Regulatory team, you will be are instrumental in building the groundwork and contributing to Intellia’s Regulatory Operations capabilities. The candidate will be part of the implementation team for Intellia’s Regulatory Information Management (RIM) System and will provide critical support for the system and regulatory submissions that support Intellia’s gene editing pipeline. The principal role you will fulfill will be:

Submission Management/Support:

  • Works with Functional Areas, Regulatory Strategy/CMC/PM in defining submission content, timelines, and document owners
  • Builds and maintains submissions in RIM (Objectives, Record, Content Plan, Submission Binder)
  • Draft submission documents with input from Regulatory Strategy/CMC/Functional Areas
  • Primary contact for Submission Techs/Publishers
  • Work with Functional Areas and Submission Techs to ensure all documents meet submission-ready standards on time
  • Finalize Submission Binders for publishing/dispatch
  • Coordinate final review/release of submissions to HAs
  • Communicate published output QC findings and facilitates resolution with input from Submission Owner/Manager

Management of Regulatory archives, Health Authority Interactions and core RIM records/data:

  • Manages regulatory archives (correspondence and submissions)
  • Maintains HAQ and Commitments databases
  • Supports the creation/maintenance of core records/data

Support RIM System implementation/maintenance/enhancements and Business Process improvements

About You:

If you are looking to immediately become a key contributor on a team where you will work with a first-in-class RIM system in managing submissions and regulatory information, this is opportunity is for you! We are looking for a detail-oriented candidate who takes pride in delivering quality work and learning new skills. Industry experience is a plus.

Meet your future team:

The Regulatory team is growing quickly! We have expanded from two people to a team of 7 over the last year. This is an exciting time to join us, as we are starting to build out a regulatory infrastructure that will be needed to support our ambitious regulatory and clinical goals for our investigational products. The team is small, friendly and genuinely enjoy working with each other. We are a passionate group of individuals on a mission to pioneer the approval of CRISPR therapies.

The team is currently working off-site during the COVID pandemic. As the situation improves there are plans to meet once or twice a month as a regulatory group with the flexibility to be on site as much as you prefer. If you join our team, you can expect to join a hardworking and collaborative environment. We look forward to fostering your skills, learning from your experiences, and building a larger team that will make a difference in patients' lives.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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