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.
- Provide regulatory input into clinical study designs, protocols, investigator brochures, informed consent documents, safety reports, and other clinical trial documentation.
- Monitor regulatory requirements, guidance documents, precedents, and competitive intelligence relevant to oncology, immunotherapy, cell therapy, gene therapy, biologics, and rare or serious disease development.
- Support cross-functional teams by identifying regulatory risks, proposing mitigation strategies, and helping ensure alignment with program objectives and evolving health authority expectations.
- Help maintain regulatory submission plans, timelines, trackers, and documentation to support inspection readiness and lifecycle management.
- Contribute to the development of internal regulatory processes, best practices, templates, and standards as the regulatory function grows.
- Represent Regulatory Affairs on assigned project teams and act as a trusted partner to cross-functional colleagues.
The successful candidate will have:- Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related field required; advanced degree preferred.
- Senior Manager: 6+ years of relevant regulatory affairs experience.
- Associate Director: 8+ years of demonstrated experience supporting clinical-stage drug, biologic, cell therapy, oncology, immunology, or rare disease programs.
- Strong understanding of clinical regulatory strategy and regulatory operations across U.S., EU, and global markets.
- Excellent written and verbal communication skills, with the ability to prepare clear regulatory documents and executive-level summaries.
- Strong project management, organizational, and prioritization skills with the ability to manage multiple deliverables in a dynamic environment.
- Collaborative working style with the ability to influence without authority and build productive cross-functional relationships.
- Sound judgment, attention to detail, and ability to identify regulatory issues early and propose practical solutions.
- Comfort operating in a growing organization where processes are evolving and individuals are expected to be hands-on, adaptable, and accountable.
- Commitment to patient-focused drug development and high standards of quality, compliance, and scientific integrity.
Preferred Qualifications: - Hands-on experience with FDA submissions and interactions, including INDs, protocol amendments, annual reports, safety reports, briefing packages, and responses to information requests.
- Experience supporting EU and/or broader global clinical trial applications and health authority interactions, including CTAs, substantial amendments, and engagement with EMA or national competent authorities.
- Working knowledge of ICH guidelines, FDA regulations, EU Clinical Trials Regulation requirements, GCP, and global clinical development expectations.
- Experience in biotechnology, pharmaceutical, or cell and gene therapy environments preferred.
- Demonstrated ability to interpret regulatory guidance, assess implications for development programs, and communicate recommendations clearly to cross-functional teams.
Physical Requirements:- Ability to travel as needed.
- Ability to sit for prolonged periods of time.
- Ability to work evenings, holidays and weekends as needed.
- If based in Seattle, WA, ability to work on site at our Seattle office 2 days/ week.
Senior Manager Level Salary Range: $159,800 - $197,400Associate Director Level Salary Range: $164,500 - $202,650Benefits OfferingsUmoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the
Benefits section of our website.
