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.
Reporting to the Vice President, Regulatory Affairs, the Regulatory Manager will be responsible for the development and submission of regulatory filings for CRISPR/Cas9- based in vivo gene therapy projects, in the US and internationally. The individual 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.
As a member of project teams, provide strategic regulatory support for multiple in vivo 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
Accountable for all submissions and approvals for assigned project(s)
Direct point of contact with health authorities and management of FDA/global health authority interactions/meetings for project responsibilities with direction from regulatory management; 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
Minimum 5 years pharmaceutical industry experience in Regulatory Affairs. Experience in other relevant functions within a biopharmaceutical environment a plus. BS in a scientific discipline required with an advanced degree preferred (PharmD, PhD, MS, MPH).
Excellent written and communication skills, strong technical knowledge, including regulatory writing
Basic working knowledge of drug development process and regulatory requirements in US and EU. Japan, Canada and ROW a plus
Experience with biologics and/or gene and cell therapies a plus.
Detail oriented; science-based reasoning skills
Ability to execute and follow-through to completion and documentation
Ability to work in a fast-paced, start-up environment
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
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.