CRISPR Therapeutics Manager/Senior Manager, Regulatory Affairs CMC in Cambridge, Massachusetts
CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom.
In this position you will provide critical support in developing and executing CMC regulatory strategies for CRISPR’s portfolio of allogeneic CAR-T cell therapies. You will work in close collaboration with Technical Operations, Quality, and global development teams, to ensure timely preparation and submission of high-quality CMC dossiers. This role offers an exceptional career-growth opportunity for a highly motivated individual, to join a company focused on science, innovation, collaboration and entrepreneurship, and have meaningful impact on patients.
Work closely with the RA CMC lead for each program to develop Regulatory strategy
Ensure that CMC-related Regulatory submissions meet relevant requirements to achieve timely approval
Participate collaboratively in CMC teams and Global Regulatory teams
Maintain understanding of evolving Regulatory expectations for cell and gene therapy
Help evolve Regulatory CMC business practices with key stakeholders, as the group continues to grow
A Bachelor’s degree in a scientific field (e.g. biology, chemistry, or related pharmaceutical field), advanced degree preferred
Experience in relevant biopharmaceutical industry CMC functions (5+ years for Manager, 7+ years for Senior Manager)
Direct experience in Regulatory Affairs CMC strongly preferred
Fundamental understanding of FDA, EMA, and ICH CMC guidelines, and Health Authority expectations for CMC dossiers
Excellent communication and organizational skills, and the ability to manage multiple priorities within a dynamic organizational and team structure
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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