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. 

RESPONSIBILITIES:

• 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

QUALIFICATIONS:

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

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