Oversee quality compliance for combination products, ensuring regulatory standards and company objectives are met.
Develop and implement quality strategies in collaboration with cross-functional teams and external partners.
Stay current with global device and combination product regulations, supporting audits and design control oversight.
Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Founded in 2016 and based in Brisbane, California, the company fosters a culture of empathy, urgency, and an owner's mindset.
Manage GMP manufacturing operations and contracted manufacturing operations focused on protein production and downstream processes.
Collaborate with cross-functional teams including Process Development, Analytical Development, Manufacturing, Quality, and Regulatory.
Provide technical leadership for process transfer, scaleup, validation, and improvements, and support regulatory filings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, and offer a diverse and inclusive work environment.
Drives strategic growth by generating high-value partnerships for the proprietary AJIPHASE® platform.
Coordinates technical project management and CMC alignment between North American clients and manufacturing teams in Japan.
Negotiates and structures MSAs and SOWs to secure new clinical and commercial API pipelines.
Ajinomoto Co., Inc. is a global leader in amino acid science, biotechnology, and healthcare, with an expanding presence in biopharmaceutical contract manufacturing. Forge Biologics, its U.S. subsidiary, brings proprietary Japanese biomanufacturing technologies to the North American market, with a focus on innovative oligonucleotide and peptide synthesis.
Review CMC sections of regulatory submissions for drug-device combination products, ensuring accuracy and alignment with global requirements.
Contribute to global regulatory CMC strategies and provide guidance to cross-functional stakeholders.
Collaborate with device development, quality, clinical, human factors, and other teams to support product compliance and change controls.
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.
Lead and manage internal chemistry resources and CRO teams to identify IND-ready candidate molecules.
Serve as chemistry leader within multidisciplinary project teams, building effective relationships across geographically dispersed collaborators.
Use SAR analysis and computational tools to design novel molecules and establish intellectual property.
Centessa Pharmaceuticals is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Headquartered in Boston, Massachusetts, it was recognized as a Great Place to Work in 2026.
Design and deliver ongoing skill and capability development programs for Territory Managers and Regional Sales Directors.
Build scalable coaching frameworks and reinforcement resources to embed learning into daily selling activities.
Partner with sales leadership, analytics, and HR to translate performance data into targeted development initiatives.
A pharmaceutical and biotech organization is seeking a Director of Sales Capability and Performance Development. The company is growing and focuses on commercial launch preparation and field development.
Lead pharmacovigilance strategy and operations across the portfolio, ensuring regulatory compliance and safety oversight.
Oversee outsourced PV vendors, build quality systems, and manage safety data exchange agreements.
Partner cross-functionally with Clinical Development, Regulatory, and Quality to advance pipeline from early to late-stage development.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases. It is a lean organization with a build-oriented culture, advancing a pipeline from Phase 1 to Phase 3.
Support GMP CMC operations including review of batch records, analytical data, and product release for clinical-use drug substances and products.
Manage quality oversight for GMP vendors, audits, and quality agreements, and act as a QA point of contact for internal and external partners.
Review and approve quality events such as OOS, deviations, CAPAs, and change controls to ensure regulatory compliance.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for patients with cancer, targeting the RAS/MAPK pathway. With a small, collaborative team and a casual, mission-driven culture, they are committed to erasing cancer.
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.
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.
Lead product vision and strategy for attack surface management and supply chain risk, translating technical challenges into customer value.
Manage and develop a high-performing team of Product Managers, partnering with Engineering, Design, AI, and other teams.
Engage directly with customers and stakeholders to identify opportunities and drive product direction in a fast-paced, high-growth environment.
The company provides cybersecurity and Internet intelligence solutions, helping organizations understand, monitor, and secure their Internet presence. It is a high-growth environment that values innovation, adaptability, and measurable business impact.
Drive lifecycle strategy to expand the impact of late-stage and marketed assets across new indications and formulations.
Lead early clinical development including first-in-human studies and data-driven dose selection.
Provide pipeline-wide clinical leadership and represent Praxis with health authorities and partners.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company fosters a culture of trust, ownership, curiosity, and results, with a collaborative team focused on high-impact medicines.
Lead extraction and formulation strategy, driving innovation and operational excellence across multi-site facilities.
Oversee compliance with federal, state, and local regulations, maintaining high safety standards.
Build and mentor a high-performing team, fostering a culture of collaboration and continuous improvement.
Green Thumb is a cannabis company that produces and sells cannabis and hemp extracts in Vape, Concentrates, and Edibles categories. It is a multi-state operation with a focus on innovation and quality, fostering a collaborative culture.
Oversee strategic planning and execution of global clinical studies.
Manage internal and external resources, including CROs, to ensure quality and compliance.
Lead cross-functional teams and contribute to trial design and budgeting.
Dianthus Therapeutics is a clinical-stage biotechnology company developing novel therapies for severe autoimmune diseases. The company values a culture centered on core principles and aims to elevate patient care.
Lead global pharmacovigilance audits, regulatory inspections, and readiness planning.
Oversee issue management, deviations, root-cause analysis, and CAPA activities.
Develop and manage the global pharmacovigilance training program and procedural documentation.
Our partner is a fast-growing biopharmaceutical company focused on improving outcomes for patients with severe autoimmune diseases. It offers a collaborative environment with opportunities for professional growth and leadership development.
Own the full Business Development cycle for early-phase programs, from identifying opportunities to closing contracts.
Develop account and territory strategies, build executive relationships, and convert complex client needs into scalable solutions.
Collaborate with internal teams to ensure program success and fuel growth for the organization and patient impact.
FUJIFILM Biotechnologies is a contract development and manufacturing organization (CDMO) that partners with innovative biopharma companies to develop and manufacture vaccines, biologics, and gene therapies. The company is part of FUJIFILM, a global leader with over 70,000 employees, and fosters a culture of passion and energy known as 'Genki'.
Lead scientific strategy and content development for oncology-focused medical communications programs.
Serve as a senior scientific partner to clients, driving brand planning and new business initiatives.
Manage multiple projects with rigorous editorial standards and cross-functional collaboration.
This role is listed on behalf of a partner company that provides AI-powered job matching services. Jobgether is a platform that uses AI to connect candidates with hiring companies, emphasizing efficiency and objectivity in recruitment.
Lead author on complex regulatory and clinical documents including protocols, CSRs, IBs, and IND/NDA/BLA submissions.
Provide strategic input on document planning, messaging, and quality control while mentoring other writers.
Manage multiple projects independently, balancing timelines and client expectations in a fully remote environment.
Eldridge Writing provides top-tier medical writing services to pharmaceutical and biotechnology clients. We are a small, collaborative team that values quality and serves as a true extension of our clients’ teams.
Execute analytical strategies for commercial products, ensuring compliance and method lifecycle management.
Lead method transfer, validation, and investigations at CDMOs, supporting regulatory submissions.
Serve as analytical SME, partnering cross-functionally to ensure quality and supply continuity.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. The company fosters a culture of trust, ownership, curiosity, and results with a collaborative team.
Provide study oversight as the primary liaison between CRAs, site staff, clients, and vendors across all study stages.
Ensure clinical monitoring activities comply with SOPs, regulations, GCPs, and study-specific requirements.
Support team training, review site visit reports, and manage oversight of the Trial Master File and eTMF.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) trusted since 1996, delivering ethical services to pharmaceutical, biotech, and medical device companies. They foster a collaborative community where team members feel valued and empowered to make a meaningful impact on global health.