Senior Director, Global Regulatory Strategy

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.

Senior Director, Regulatory Strategy

Job Summary

The Senior Director, Regulatory Affairs is a leader who provides the strategic direction of assigned products. This individual is responsible for providing strategic insight that efficiently and effectively translates regulatory requirements into practical, workable global plans on their programs. They will be accountable for the timely preparation of high quality, organized and scientifically valid regulatory submissions.

The Senior Director, Regulatory Affairs will also focus on the mentoring, growth and development of the their team as well as creating a positive and supportive culture where transparency, a sense of urgency, delivering results, integrity and personal accountability are valued.

Duties / Responsibilities

• Has in-depth and breadth of regulatory expertise and a strong track record of implementing successful business strategies for major segments of product life cycle. Recognized as an internal and external influential thought-leader
• Has led at least one major marketing application, (BLA, or MAA)
• Accountable for meeting GRT / Program Team goals (for e.g., major milestones) associated with mid / late-stage complex, global submissions spanning 3 or more geographic areas or a Marketing Authorization Application (BLA / MAA)
• Leads a team / workstream in navigating abstract situations such as major applications over long-range periods, while integrating information over parallel projects that require a deep understanding of business strategies
• Takes a broad, long-range approach to problem-solving and decision making that involves objective analysis and thinking ahead. Able to think in multiple time frames, identifying and advising on what needs to be accomplished over time to get there
• Thinks innovatively, identifying the impact of decisions on various segments of the organization.
• Full strategic responsibility for an area of significant impact. Has budget and planning oversight, including headcount. Provides input and monitors Long Range Planning horizon
• Accountable for oversight, direction, and performance of cross-functional team / workstream and executing against regulatory strategy in line with goals and deliverables with a broad impact on the organization. When needed, delegates tasks effectively and appropriately to direct focus on strategic planning and execution
• Acts as the recognized authority on regulatory matters and requires little, if any, supervision dealing with division or corporate functions, or with external agencies
• Interfaces with all levels of division and corporate management, multiple functions, and divisions. External contacts include regulatory agencies, standards setting groups, and industry groups
• Oversees budget for assigned programs, defending as needed
• Accountable for oversight, direction, and performance of workstreams executing against regulatory department goals and deliverables

Supervisory Responsibilities

Requirements

Masters of Science

Prolonged periods of sitting at a desk and working on a computer.

Covid-19 Vaccination Policy : All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

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.