Biotechnology

Senior Manager, Clinical Regulatory Affairs

RemoteRemoteFull TimeManager / Head$159,800–$197,400 /yrPosted 1 month agoVisa sponsorship available

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Required skills

in vivo CAR T
cell and gene therapy
clinical development
regulatory submissions
health authority interactions
INDs
CTAs
protocol amendments
briefing packages
health authority responses

Nice to have

FDA submissions
EU clinical trial applications
EMA
national competent authorities
ICH guidelines
FDA regulations

Role summary

Umoja Biopharma is seeking a Senior Manager/Associate Director, Clinical Regulatory Affairs to drive clinical regulatory strategy and execution for their innovative in vivo CAR T and cell and gene therapy programs. This role involves supporting global regulatory submissions and health authority interactions across the US, EU, and other markets. The ideal candidate will have strong clinical development experience, sound regulatory judgment, and the ability to thrive in a fast-paced biotechnology environment. Responsibilities include developing regulatory strategies, preparing submissions (INDs, CTAs), collaborating with cross-functional teams, and providing regulatory input on clinical documentation. Monitoring regulatory requirements and contributing to process development are also key aspects of this position.

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.

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.

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 - $202,650

Benefits Offerings

Umoja 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.

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