Job Title: Director, Regulatory Affairs
Job Location: Seattle, WA, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Director
Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.
We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families. Umoja Biopharma – Your Body. Your Hope. Your Cure. Position Summary The Director, Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible for content development, compilation, maintenance, and review of the Nonclinical and Clinical Modules for regulatory submissions to support Umoja’s drug products including, DMF, IND and NDA/BLA applications, Health Authority (HA) responses, and briefing packages (including participating in/leading HA meetings). In this role, the Director will represent Regulatory Affairs on the technical teams, participate in internal development team(s), and interface with external contractors/consultants. This key role will develop and implement regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with cancer and unmet needs. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities. Core Accountabilities Specific responsibilities include: Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
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