Director, Regulatory Strategy
5 months ago
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:
Intellia will have three Phase 3 programs leading into global marking applications As the Director, Regulatory Strategy you will be both a strategic and hands-on role. You will have the opportunity to leading these registration programs. 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 The principal role you will fulfill will be:
Understanding and interpreting complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects, and provides knowledge and expertise to guide the team on appropriate regulatory strategies
Manage preparation and submission of high-quality dossiers and clinical trial applications in the US, EU, Japan, and ROW. This will require cross-functional interactions, excellent writing skills, as well as a good grasp of the underlying science
Assuming direct point of contact with health authorities, lead transparent and proactive interactions with global health authority interactions for project responsibilities
Driving 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
Partnering very closely with Nonclinical, Tech Ops, Quality and Clinical groups to ensure achievement of submission deadlines and obtain timely approvals
About You:
If you are looking to immediately become a key contributor on a team where , this is 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 8 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. Vice President, Regulatory Affairs. 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 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.
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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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