Associate Director, Regulatory Affairs CMC

Company: Initial Therapeutics, Inc.
Location: Cambridge
Posted on: May 24, 2025

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:Reporting to the Director, Regulatory CMC, the Associate 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 help drive the development of innovative CMC regulatory strategies to support regulatory submissions, in close collaboration with the CMC team, the internal technical functions, 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.Responsibilities:

• Provide regulatory CMC strategic leadership to support development of early and late phase gene and cell therapy products for the treatment of genetic diseases.
• Support preparation of high-quality clinical trial applications in the US, EU, and ROW.
• Work closely with the technical team and regulatory project managers to ensure achievement of submission deadlines.
• Independently manage responses to CMC questions from health authorities.
• Design and drive negotiations with regulatory agencies globally in preparation for late phase clinical development and marketing applications.
• Support interactions with regulatory agencies during GMP and pre-approval inspections.
• Work closely and creatively with technical teams to support implementation of manufacturing and analytical development strategies.
• Identify and clearly communicate regulatory opportunities and challenges to both the technical team and the clinical regulatory strategy team and develop strategies to maximize the probability of regulatory success.
• Represent Intellia at external trade associations and conferences and analyze regulatory guidelines and regulatory trends/expectations in the fast-evolving field of cell- and gene-therapy. Educate and communicate learnings to the rest of the company to inform others of new and relevant information and any implications to current programs.
• Support the development of internal regulatory processes and standards.
• Ensure regulatory compliance with existing guidelines and expectations through timely assessment of change controls and deviations, and timely completion of quality trainings.About You:Our ideal candidate will have directly contributed or led a major marketing application for cell and/or gene therapy products. If you describe yourself as a creative mind, excellent communicator, and team player, we encourage you to apply and grow with us! Other desired skills include:
  • Master's degree or higher in life sciences in biochemistry, chemistry, biology (cell/molecular) or related pharmaceutical fields including biochemical engineering.
  • Minimum 6-8 years of relevant biopharmaceutical industry experience, with at least 5 years of experience in CMC-focused Regulatory Affairs for biologics
  • Experience working with cell and/or gene therapy products or mRNA-based therapeutics is strongly preferred.
  • Early and late-stage regulatory CMC program/project leadership (Phase I/II and Phase III IND/CTA, MAA/BLA) and experience with viral vectors is desirable.
  • Led 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.#LI-KO1Covid-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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Keywords: Initial Therapeutics, Inc., Weymouth , Associate Director, Regulatory Affairs CMC, Executive , Cambridge, Massachusetts