Rubius Therapeutics is a clinical-stage biopharmaceutical company that is generating red blood cells and engineering them into an entirely new class of allogeneic, off-the-shelf cellular medicines. Our Red Cell Therapeutics™ can potentially be used to replace missing enzymes for patients living with rare enzyme deficiencies, kill tumors in cancer and regulate the immune system for the treatment of autoimmune diseases. We expect to begin enrolling patients in our first clinical trial during the second quarter of 2019, which is evaluating RTX-134 for the treatment of phenylketonuria, an inherited metabolic disorder. Additionally, we plan to file our first oncology IND for RTX-240 for the treatment of solid tumors by early 2020. In total, we plan to file four to five INDs during 2019 and 2020.
We are proud of our passionate, high-performance culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2013, we are based in Cambridge, MA and currently expanding across all functions within the organization. Having completed our initial public offering in July 2018, (Nasdaq: RUBY), we are well capitalized to execute our vision of creating life-changing cellular medicines. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com or follow us on Twitter and LinkedIn .
We are looking for a Director/Sr. Director, Regulatory Affairs to join our team and provide regulatory leadership in support of the development programs at Rubius. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This person will represent the regulatory function on multi-disciplinary product development teams and must integrate overall Rubius goals into the objectives and activities of the regulatory affairs department. The person in this role serves as a resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for therapies from the preclinical stage through marketing applications, and ultimately life cycle management.
Cedar Rapids, IA, United States
Consultant, Enterprise Solutions Delivery...
100 Winners Circle, Suite 300 Brentwood, Tennessee 37027 (978) 624-4594