Clinical Regulatory Affairs Manager

Umoja Biopharma is an industry-leading biotech 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 our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals.  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 Senior Manager/Associate Director, Clinical Regulatory Affairs will support and help drive clinical regulatory strategy and execution for Umoja Biopharma’s innovative in vivo CAR T and cell and gene therapy programs. Reporting to the Senior Director, Clinical Regulatory Affairs, this individual will contribute to the development, preparation, and maintenance of global regulatory submissions and health authority interactions in support of clinical development programs across the United States, European Union, and other global markets. 

This role is ideal for a regulatory professional with strong clinical development experience, sound regulatory judgment, and the ability to work effectively in a fast-paced biotechnology environment focused on advancing novel, complex therapies for patients with serious diseases. 

We will consider candidates at either the Senior Manager or Associate Director level based on the candidate’s qualifications and experience.  

CORE ACCOUNTABILITIES:

Specific responsibilities include: 

• Support the development and implementation of global clinical regulatory strategies for assigned programs, including early- and mid-stage clinical development plans. 
• Contribute to the preparation, review, and submission of regulatory documents, including INDs, CTAs, protocol amendments, annual reports, briefing packages, health authority responses, and components of marketing applications as applicable.
• Partner with clinical development, clinical operations, medical writing, pharmacovigilance, CMC, nonclinical, program management, and external regulatory consultants to ensure high-quality, timely regulatory deliverables.
• Assist in planning and preparing for FDA, EMA, national competent authority, and other global health authority meetings, including development of briefing materials, questions, responses, meeting strategy, and post-meeting documentation.