Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and helping transform how autoimmune diseases are treated.

is seeking an experienced and driven Manager of Regulatory Affairs to join our regulatory team in a Contract position. This role is pivotal in shaping and executing regulatory strategies for our innovative therapies. We are looking for candidates with a proven track record in Clinical/Nonclinical Regulatory Affairs within the biotechnology or pharmaceutical sector.

Title: Manager of Regulatory Affairs, Consultant

Reports to: Executive Director, Regulatory Affairs

Location: Remote (West Coast hours preferred)

• Bachelor's or advanced degree in a relevant scientific field.

• Minimum of 2-5+ years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector.

• Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs.

• Experience with cell or gene therapy regulatory affairs.

• Experience with CTD/eCTD and life cycle management.

• High attention to detail, strong organizational skills, and project management capabilities.

• Effective communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams.

• Ability to adapt to a dynamic regulatory environment.