Manager, Regulatory Affairs

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:

We are excited to welcome this new member to our growing team and company. This is both a strategic and hands-on role. If you are an independently motivated and results oriented person who enjoys collaborative team-oriented environments where results are achieved through influence and the incorporation of multiple points of view, this is the role for you! As the Regulatory Affairs Manager in Global Regulatory Strategy, you will work on various projects including:

• Supporting the development of global regulatory strategy for Intellia’s innovative genome editing pipeline

• Understanding complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects, and providing knowledge and expertise to guide team in appropriate regulatory strategy

• Supporting the preparation of high-quality global regulatory submissions including Investigational New Drug Applications/clinical trial applications, orphan drug applications and special designation applications

• Supporting global health authority interactions/meetings for project responsibilities; managing the creation and submission of briefing documents

• Partnering very closely with Nonclinical, Clinical and other functional groups to ensure achievement of submission deadlines and obtain timely approvals of clinical trial applications

About You:

You will have a bachelor’s degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering, with a minimum 6 years of relevant biopharmaceutical industry experience, and at least 3-4 years relevant biologics/drug Regulatory Affairs experience. Ideally, your experience would include gene or cell-based therapeutics, RNA-based therapeutics and/or orphan drug development. Excellent written and verbal communication skills, including regulatory writing, are essential. You will be detailed oriented and have strong science-based reasoning skills. You will have strong leadership qualities including strategic thinking, innovation, mentoring and collaboration.

Meet your future team:

The Regulatory Affairs group is a rapidly growing team within Intellia and includes professionals with diverse regulatory expertise in both large pharma and small biotech settings. You will report to the Sr. Director, Global Regulatory Strategy. The team leads all regulatory strategy and implementation for Intellia’s in vivo and ex vivo development candidates and the rich pipeline products in research.

The team is currently working virtually and there are plans to return into the Cambridge MA office as the pandemic situation improves. Although in a virtual environment, the Regulatory Affairs team has made it a priority to continue to foster a sense of community among the group. If you join our team, you can expect to join a hardworking, collaborative environment. We look forward to fostering your skills, learning from your experiences, and building a larger team that will make a difference in patient’s 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.