Provide strategic quality leadership for CMC activities across cell therapy programs.
Lead product quality strategy and lifecycle management with risk-based control strategies.
Oversee QC operations and external partner quality oversight.
BrainChild Bio is a clinical-stage biotechnology company developing CAR T cell therapies for central nervous system tumors. The company prioritizes pediatric brain tumors with a pipeline extending to adult indications, and every team member directly impacts bringing therapies to patients.
Develop and implement global CMC regulatory strategies for biologic and combination products.
Prepare and manage CMC submissions, briefing documents, and health authority meeting packages.
Serve as the CMC Regulatory lead on cross-functional project teams and support health authority interactions.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. The company is a small, dynamic organization with a collaborative culture and a strong focus on regulatory excellence.
Support and contribute to global regulatory strategies to expedite development and mitigate risks.
Plan, prepare, and coordinate regulatory documents for submissions to global health authorities (INDs, BLAs, MAAs, etc.).
Collaborate with cross-functional teams and support interactions with FDA and other Health Authorities.
Immunovant, Inc. is a clinical-stage immunology company developing targeted therapies for autoimmune diseases. As a rapid-growth biotech startup, it fosters a dynamic, fast-paced, and entrepreneurial environment.
You will lead global regulatory strategy for drug development programs, focusing on Ex-US health authorities.
You will manage and create high-quality regulatory submissions, including Clinical Trial Applications and Market Applications.
You will collaborate cross-functionally to negotiate optimal development paths and ensure compliance with evolving regulations.
Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is committed to innovation in cell therapy and has a clinical-stage pipeline.
Provide strategic pharmaceutical development guidance as CMC lead to cross-functional project teams.
Develop robust formulations and manufacturing processes to support rapid registration of QED products.
Manage CRO relationships, drug forecasts, and regulatory submissions for clinical supply.
BridgeBio is a biotech company pioneering a 'moneyball for biotech' approach to reduce risk and accelerate development of life-changing medicines for rare diseases. They foster a culture of curiosity and experimentation, working alongside respected industry minds to reengineer the future of biopharma.
Provide quality oversight and direction to vendors to ensure cGMP compliance for clinical manufacturing.
Lead clinical lot disposition, batch record review, and QP certification for global trials.
Oversee GMP quality systems including deviations, investigations, and audits at contract manufacturing partners.
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for pulmonary diseases. It is a small, lean organization within the Roivant family, focusing on collaboration and innovation.
Lead global regulatory strategy for assigned programs, overseeing processes and managing risks to achieve successful registration and lifecycle management.
Collaborate cross-functionally with teams including toxicology, pharmacology, and clinical development to support clinical programs and regulatory submissions.
Serve as point of contact with health authorities, interpret regulatory guidelines, and drive innovative approaches to regulatory sciences.
Recursion is a clinical-stage TechBio company that uses AI and technology to decode biology and accelerate drug discovery and development. The company employs hundreds across multiple global offices and values integrity, collaboration, and bold action.
Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.
Serve as the CDx regulatory subject matter expert, developing global regulatory strategies for companion diagnostics and clinical trial assays.
Lead interactions with regulatory authorities and direct the preparation of global submissions, including FDA Q-Submissions, IDEs, PMAs, and EU IVDR applications.
Partner cross-functionally with pharmaceutical and diagnostic clients to align diagnostic development with therapeutic milestones and commercialization objectives.
Precision Medicine Group provides regulatory consulting services to pharmaceutical, biotechnology, and diagnostic clients, specializing in companion diagnostics and precision medicine. The company fosters a collaborative, client-focused culture with a team of regulatory experts.
Provide strategic regulatory leadership for companion diagnostics (CDx) and precision medicine programs across global markets.
Lead consulting engagements, guiding clients through FDA, EU IVDR, and international regulatory pathways from development to commercialization.
Mentor consulting team members and contribute to a collaborative regulatory practice focused on precision medicine innovation.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. It operates remotely with a focus on efficiency and data privacy.
Develop and execute a global training strategy tailored to cell therapy programs across clinical and commercial stages.
Build role-specific onboarding, certification, and continuous learning pathways for Medical and Commercial field teams.
Deliver comprehensive training including disease state education, CAR T product design, clinical data, safety monitoring, and competitive landscape.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. It is a scaling biotech environment with a culture driven by core values of collaboration, clarity, innovation, and ownership.
Lead regulatory and quality strategy for product development and lifecycle management.
Coordinate regulatory submissions and maintain documentation for SaMD products.
Support design change assessments and ensure compliance with FDA, EU MDR, and ISO 13485.
Oura empowers people to own their inner potential through its award-winning Oura Ring and connected app, providing daily insights on readiness, activity, and sleep. As a quickly growing health technology company, Oura fosters a culture of empowerment and well-being, ensuring team members have the resources to do their best work.
Manage analytical development, QC, and stability activities at contract manufacturing sites.
Author and review CMC sections for US and ex-US regulatory filings.
Collaborate with Quality Assurance to close investigations and manage change controls.
BridgeBio is a biotech company that pioneered a 'moneyball for biotech' approach, pooling projects and early-stage research to reduce risk and develop medicines for rare diseases. They foster a culture of curiosity and experimentation with small teams of experts.
Develop and execute a comprehensive global training strategy for cell therapy programs across clinical and commercial stages.
Build role-specific onboarding, certification, and continuous learning pathways for Medical, Commercial, and other teams.
Ensure training content complies with FDA, EMA, and global regulatory requirements while measuring competency and launch preparedness.
The company is a clinical-stage biotechnology organization developing innovative advanced therapies. It operates in a fast-paced, collaborative environment with a focus on launch readiness and cross-functional teamwork.
Lead scientific validation and regulatory qualification strategies to accelerate adoption of Advanced Cell Models solutions.
Drive U.S. regulatory acceptance activities including FDA ISTAND Pilot Program and DDT qualification pathways.
Build scientific collaborations with key opinion leaders and academic institutions to strengthen external scientific credibility.
Sartorius accelerates the development and production of innovative therapies for better health. As a global life science company listed on the German DAX and TecDAX, they offer a wide range of benefits and a welcoming culture.
Manage regulatory activities for complex submissions across EU, GCC, and Australian markets.
Conduct regulatory research, gap analyses, and prepare submission components.
Provide regulatory expertise within multidisciplinary project teams and support business development.
The company provides regulatory consulting services for healthcare products, focusing on global markets. It fosters a collaborative, inclusive culture with opportunities for career development and meaningful impact.
Prepare and manage clinical trial submissions to Competent Authorities and Ethics Committees for initial and subsequent approvals.
Collect, review, and maintain essential documents for site activation, ensuring compliance with ICH-GCP and local regulations.
Act as Subject Matter Expert, mentoring less-experienced staff on site start-up activities and regulatory requirements.
Precision Medicine Group is a life sciences organization that provides clinical trial and regulatory services to biopharmaceutical companies. They are expanding their presence in Latin America and foster a collaborative, fast-paced culture focused on precision medicine.
Provide end-to-end Product Quality oversight for clinical and commercial programs, including drug substance, drug product, packaging, and labeling.
Lead resolution of deviations, OOS/OOT, change controls, CAPAs, and product quality complaints with risk-based decisions.
Represent Product Quality on CMC and external partner teams to support development, regulatory submissions, and commercialization.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company values trust, ownership, curiosity, and results, fostering a culture of diversity and inclusion with a small but dedicated team.