Senior Manager, Clinical Regulatory Affairs

Umoja Biopharma

. Support the development and implementation of global clinical regulatory strategies for assigned programs, including early- and mid-stage clinical development plans .

Posted 9/15/2026full-timeSeattle • Washington • United StatesSenior💰 $159,800 - $202,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs with a focus on clinical development, including the preparation and submission of regulatory documents such as INDs and CTAs. Proficient in navigating FDA and EMA interactions while ensuring compliance with ICH guidelines and global clinical development standards.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA SubmissionsClinical Trial ApplicationsICH Guidelines KnowledgeCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationIND SubmissionCTA SubmissionProtocol AmendmentsSafety ReportsHealth Authority InteractionsRegulatory Strategy DevelopmentClinical Study Design InputRegulatory Risk AssessmentInspection Readiness

Soft Skills

Clear CommunicationProblem-SolvingTeam CollaborationStrategic ThinkingAdaptability

Industry Keywords

OncologyImmunotherapyCell TherapyGene TherapyBiologicsRare DiseaseGCPEU Clinical Trials RegulationPharmaceuticalBiotechnology

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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 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

Requirements

What you’ll need

Senior Manager: Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or a related field required; advanced degree preferred with 5+ years of relevant regulatory affairs experience
Associate Director: Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or a related field required; advanced degree preferred with 8+ years of demonstrated experience supporting clinical-stage drug, biologic, cell therapy, oncology, immunology, or rare disease programs
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
Ability to interpret regulatory guidance, assess implications for development programs, and communicate recommendations clearly to cross-functional teams
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 the Seattle office 2 days/week

Benefits

Comp & perks

Medical plans
Dental plans
Vision plans
401k plan through Fidelity with a 100% match up to the first 4% deferral
Generous Paid Time Off policy
Employee commuter benefits
Cell phone stipend