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 want all of our 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:
Reporting to the Vice President, Regulatory CMC, the Director of Regulatory CMC will be responsible for the development and submission of regulatory filings for CRISPR/Cas9- based gene therapy projects, in the US and internationally. The individual will drive the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC sections of briefing documents, INDs, CTAs, and eventual original marketing applications (BLAs/MAAs), in close collaboration with analytical, CMC and Quality teams, contract manufacturing organizations, and external consultants and collaborators.
This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of disciplines such as nucleic acid therapeutics, lipid-nanoparticle drug delivery, viral delivery systems and a range of cell therapy products.
Provide regulatory CMC strategic leadership to support development of multiple innovative cell-based gene therapy products for the treatment of severe genetic diseases
As a member of project teams, provide strategic CMC regulatory support for multiple innovative programs
Manage and implement planning, authoring and submission of high-quality CMC‑related sections of briefing documents and clinical trial applications in the US, EU and ROW
Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections
Drive adherence to CMC 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
Guide development of manufacturing strategies for Intellia’s therapeutics, including assessing proposed manufacturing process changes and provide strategic regulatory guidance
Participate in the development of regulatory processes and standards
Partner and work very closely with CMC, Analytical Development, Quality, Nonclinical, Clinical and Regulatory to ensure achievement of submission deadlines and obtain timely approvals of CMC‑related applications
Regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to CMC teams and Project teams
Our ideal candidate will have participated in or lead a major marketing application. If you describe yourself as a great partner and team player who wants to have fun and grow with us, we encourage you to apply! Other desired skills include:
Master’s degree in life sciences in biochemistry, chemistry, biology (cell/molecular) or related pharmaceutical fields including biochemical engineering; Candidates holding a higher degree, such as a PhD will be given preference.
Minimum 10 years of relevant biopharmaceutical industry experience, with at least 8 years' experience in CMC-focused Regulatory Affairs for biologics
Experience working with cell therapy, gene therapy products or mRNA-based therapeutics is a plus
Late-stage regulatory CMC program/project leadership (Phase III IND/CTA, MAA/BLA) and experience with non-viral or viral vectors is desirable.
Direct interactions with regulatory health authorities and experience with submitting CTA/IND and BLA/MAA filings, ideally in an area related to gene therapy
Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines
Meet your future team:
The Global Regulatory Affairs group is a rapidly growing and valued team within Intellia and is comprised of respected professionals with diverse regulatory expertise in both large pharma and small biotech settings. The Regulatory CMC group is a big part of the GRA function. We are a group of bright, fun, and team first people. Eager to move exciting projects forward, we are motivated by the opportunity to make an impact for patients!
The Global Regulatory Affairs group is currently a mix of remote, hybrid, and onsite, and we are open to applicants working remotely for this role. Although in a virtual environment, the group has made it a priority to continue to foster a sense of community! You can expect to join a hardworking, collaborative environment.
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.