Associate Director, Regulatory Information Management (RIM)

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 wantall ofour 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 the Associate Director, Regulatory Information Management (RIM) joining our growing Regulatory team, you will be instrumental in the adoption and maintenance of the RIM System and contributing to Intellia’s Regulatory Operations capabilities. You will ensure continuous optimization, maximum utilization, and uninterrupted administration of the Regulatory systems and tools to support Regulatory activities including IND/CTA submissions and Health Authority Interactions (HAI). The principal role you will fulfill will be:

Regulatory Technology Lead:

• Anticipates internal and external regulatory information management challenges and recommends creative solutions

• Maintains current knowledge of regulations, best practices, and guidelines related to Regulatory technology and assesses impact on internal systems, tools, and processes

• Leads implementation and maintenance of Regulatory systems and tools partnering closely with IT and QA Validation to complete impact assessments, UAT, and manage user groups

• Administrator for Regulatory portals and gateways (e.g., SPOR, MHRA ICSR)

• Contributes to the writing, review, and implementation of standards and procedures related to Regulatory technology

• Teams up with other System/Business Administrations and Owners across Intellia to improve processes and align where necessary

Business Administrator for Veeva Vault RIM:

• Anticipates and advocates for system enhancements and functionalities, and works with RIM team to map requirements to RIM program roadmap

• Manages the creation/maintenance of core and related objects, document/binder templates, reports/dashboards, and Commitments and HAQ databases

• Actively solicits and gathers feedback to understand evolving business requirements

• Translates feedback/requirements to workable RIM solutions including development of reports/dashboards, document/binder templates, and business requested system/process enhancements

• Provides technical expertise and guidance to users to ensure process adherence including workflows, document lifecyles, Submission Content Plans, etc.

• Implements training strategies, develops training materials, and delivers training for effective adoption of RIM

• Partners with Training and IT to ensure user accounts are created in a timely manner

About You:

If you are looking to immediately become a key contributor on a team where your combination of Regulatory submission knowledge and system expertise drives the maintenance and enhancement of a first-in-class RIM system, this is opportunity is for you! We are looking for a detail-oriented candidate who takes pride in delivering quality work, defining and adhering to processes, and guiding our end users. The candidate should have

• Bachelor’s degree with 6-8 years of combined Regulatory Operations and/or RIM experience (CMC submissions and Veeva Vault RIM experience/certification preferred)

• Strong understanding of RIM systems, SDLC, eCTD, Regulatory submission/document lifecycles

• Broad and comprehensive expertise in leading-edge Regulatory Information Management concepts

Meet your future team:

The Regulatory team is growing quickly! This is an exciting time to join us, as we are building out a regulatory infrastructure that will be needed to support our ambitious regulatory and clinical goals for our investigational products. We are a passionate group of individuals on a mission to pioneer the approval of CRISPR therapies.

The team is of hybrid and remote with 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.

Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.

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.