Manage global regulatory affairs activities for Spyre's IBD program, developing strategies to enable clinical trials and marketing applications.
Lead preparation and submission of regulatory applications to FDA, EMA, and other global health authorities, ensuring timely approvals.
Collaborate cross-functionally with research, clinical, and technical teams to integrate regulatory considerations and mitigate risks.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation immunology therapies. It is a young company with a fast-paced, dynamic culture focused on advancing meaningful medicines for patients.
Contribute to regulatory strategies and coordinate interactions with health authorities.
Manage preparation and submission of INDs/CTAs, BLAs, annual reports, and safety reports.
Collaborate with cross-functional teams to ensure GXP compliance and support regulatory inspections.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases. It leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells, with a culture driven by scientists and industry veterans.
Manage regulatory submission planning, publishing, and lifecycle management for clinical programs.
Serve as SME for eCTD structure, validation, and document management technologies.
Drive process improvements and ensure compliance with Health Authority requirements.
Exelixis is a biotech company dedicated to discovering and developing innovative medicines for difficult-to-treat cancers. With over 25 years of experience, they foster a collaborative and inclusive culture focused on making a difference for patients.
Serve as CMC regulatory expert, developing global submission strategies and assessing regulatory risks for development and commercial programs.
Lead preparation and review of CMC submission content including CTD Module 2 and Module 3 sections, and support regulatory filings from IND to MAA.
Guide CMC lifecycle management, regulatory authority interactions, and monitor emerging regulations to inform client strategies.
Opus Regulatory is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo to biotech and pharmaceutical clients. Their team is made up of biopharmaceutical leaders and innovators focused on delivering the highest level of regulatory consulting service.
Oversee operational preparation and execution of regulatory submissions, ensuring technical compliance and timely delivery.
Manage routine submissions like INDs, CTAs, and health authority responses, while supporting complex filings and maintaining submission plans.
Compile, publish, and validate eCTD packages, coordinate submission delivery, and maintain accurate records in Veeva RIM.
A partner company of Jobgether, a pharmaceutical and biotechnology organization focused on developing innovative oncology therapies. The company values regulatory precision and operational efficiency across global programs, with a remote-first culture.
Prepare and publish regulatory submissions including eCTD packages for IND, CTA, and Health Authority responses.
Maintain submission plans, follow up on document readiness, and perform document- and submission-level technical QC.
Support Veeva RIM records, promotional submissions (Form FDA 2253), and submission-related projects.
Summit Therapeutics is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs. Its global team is driven by core values of integrity, collaboration, and purposeful urgency, with multiple Phase 3 clinical studies in oncology.
Provide administrative and regulatory support for the activation, maintenance, monitoring, and closeout of clinical research studies.
Assist Regulatory Coordinators with regulatory startup, continuing review, amendments, and study closeout activities.
Maintain study regulatory files and binders, ensuring documentation is complete, current, and audit-ready.
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington and operates eight clinical care sites with network affiliations in five states.
Lead global CMC regulatory strategy for the portfolio, including Phase 3 readiness and launch planning.
Serve as the company's lead CMC voice with FDA, EMA, and other global health authorities.
Build, lead, and develop a high-performing CMC Regulatory team as the company scales.
Kailera Therapeutics is a biopharmaceutical company developing novel therapies for obesity and related conditions. The company has an entrepreneurial, team-oriented culture and is passionate about creating an inclusive workplace.
Develop and implement global regulatory strategies for oncology programs from early development through post-marketing.
Lead preparation and submission of INDs, NDAs, and other regulatory filings to ensure compliance and quality.
Provide strategic regulatory guidance and cross-functional collaboration to drive program success.
Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines for cancer, neurologic and autoimmune disease. They cultivate an inclusive culture that values curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.
Serve as the Responsible Person for wholesale distribution, ensuring GDP compliance and quality oversight.
Lead and develop the quality team and manage the Quality Management System across the entity.
Provide quality oversight of contract service providers, review batch records, and prepare for regulatory inspections.
BridgeBio is a biotech company pioneering a pooled project model to accelerate early-stage research for rare diseases. The company fosters a collaborative culture with small expert teams, encouraging curiosity and experimentation.
Lead GCP quality for clinical studies as the primary Quality point of contact from start-up through close-out.
Build the GCP quality framework, authoring SOPs, quality plans, and risk management aligned with ICH E6(R3).
Qualify and audit CROs, clinical sites, and vendors, and partner on inspection readiness.
Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.
Provide expert regulatory guidance to pharmaceutical and biotech C-suite executives, shaping critical development and portfolio decisions.
Generate new business and meet sales targets while leading complex regulatory engagements and mentoring team members.
Represent Lumanity at industry forums and contribute to practice innovation and thought leadership.
Lumanity is a global strategic partner dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. The company brings together strategy, evidence, engagement, and technology to engineer breakthrough value for biopharma clients.
Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.
Precision Medicine Group provides clinical trial services, including regulatory and site start-up support. The company is expanding across Latin America and values expertise, collaboration, and compliance.
Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.
Develop and execute the Quality practice's long-term growth strategy, expanding service offerings for biotech and pharma clients.
Build and scale a high-performing Quality organization with strong P&L ownership and delivery excellence.
Serve as a trusted advisor to executive leadership teams, providing strategic GxP quality leadership and oversight.
Syner-G accelerates breakthrough science and delivery of life-enhancing therapies through expertise, insight, consulting and management skills. The company was recently honored with BioSpace's "Best Places to Work" 2026 award for the third consecutive year, fostering a culture of growth, learning, and reward.
Lead regulatory operations across the portfolio and build/manage the Regulatory Information Management System.
Drive submission planning and execution for regulatory submissions, including DSURs, IBs, and marketing applications.
Establish efficient processes for regulatory records, document management, publishing, and health authority correspondence.
Erasca is a clinical-stage precision oncology company focused on discovering, developing, and commercializing medicines for patients with cancer. The company fosters a casual, collaborative, and entrepreneurial culture in a small or mid-sized biotech environment.
Serve as primary point of contact for testing sites ensuring protocol compliance and data quality.
Drive operational execution of clinical studies from start-up to close-out.
Collaborate with cross-functional teams to align on study execution and quality expectations.
Natera is a global leader in cell-free DNA testing dedicated to oncology, women's health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.
Manage regulatory submissions and site activation readiness across the UK.
Negotiate budgets and contracts with sites and vendors.
Coordinate with ethics committees and competent authorities for approvals.
Precision for Medicine is a global Clinical Research Organization that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics, and a passion for rare diseases and oncology. The company values growth and innovation, fostering a collaborative and inclusive environment.
Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.
The company is a biopharmaceutical organization focused on developing innovative therapies for patients with significant unmet medical needs. It operates as a remote, cross-functional team with a culture emphasizing regulatory excellence, collaboration, and career development.
Ensure product complaint investigations and procedures comply with FDA QSR, ISO, and Medical Device Directives for Vigilance.
Perform FTIR analysis and program mechanical lab equipment such as Chatillon to support material identification and complaint investigations.
Provide audit support and enforce compliance with equipment maintenance, hazmat, biohazard, and disposal management protocols.
Embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. We are expanding our portfolio of solutions to serve more patients, healthcare providers, and communities worldwide.