Associate Director, Regulatory Strategy

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Job description

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 Associate Director, Global Regulatory Strategy you will:

• Serve as the Global Regulatory Program Lead for one or more programs.

• Drive development of regulatory strategy to enable initiation of clinical development and clarify path to registration for novel gene therapies.

• Interpret regulations, policies, and guidelines and advise cross-functional teams on regulatory requirements to support development.

• Lead the planning, preparation (including authoring where relevant) and execution of regulatory submissions for assigned program.

• Represent regulatory on the program team and present to company committees as needed

• Serve as a liaison within internal departments at Intellia, with CROs, and with regulatory personnel at the various Health Authorities

• Keep abreast of changing regulations, guidance documents, and relevant technical/scientific developments

• Support other projects as assigned.

About You:

If you are looking to immediately become a key contributor on a team, this 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:

• Minimum B.S. in biochemistry, chemistry, biology, or biochemical engineering, or related life science field, with a minimum of 6 years of relevant biopharmaceutical industry experience, ideally with biologics experience in Regulatory Affairs

• Preferred experience would include gene or cell-based therapeutics, RNA-based therapeutics, and/or orphan drug development

• A proven track record, ideally with BLA or MAA experience

• Expertise with drug development across all phases of clinical development is required as well as deep experience with global regulatory health authorities (e.g. FDA, EMA) and different submission types

• Excellent written and verbal communication skills, including regulatory writing, are essential

• To be successful in this role, you will need to have strong leadership skills such as strategic thinking, innovation, and mentorship

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, Regulatory Affairs. The team leads all regulatory strategy and implementation for Intellia's in vivo candidates and the rich pipeline products in research.

The team is a mix of hybrid and remote with plans to meet quarterly 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, 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.

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