Serve as a trusted CMC advisor to clients, providing strategic guidance across all phases of product development.
Lead and manage CMC development activities for drug substances and drug products, ensuring alignment with program objectives and regulatory requirements.
Oversee CDMO/CMO selection, qualification, contracting, and ongoing management.
Provide strategic and technical leadership for CMC activities, overseeing technology transfer, scale-up, and cGMP manufacturing for small molecule drug development.
Manage contract manufacturing organizations and author regulatory submission sections to ensure alignment and timely achievement of program milestones.
Collaborate cross-functionally with Quality, Regulatory Affairs, and Supply Chain to support clinical and commercial goals from Phase I through commercialization.
Travere Therapeutics is a biopharmaceutical company dedicated to identifying, developing, and delivering life-changing therapies for people living with rare disease. The company is a dedicated team focused on meeting the unique needs of rare patients, fostering a collaborative, diverse, and fast-paced environment centered on patients, courage, community, and collaboration.
Lead CMC regulatory activities for IND/CTA development and maintenance to support clinical trials and future MAA/NDA/BLA submissions.
Prepare and review CMC regulatory documents, assess changes, and collaborate cross-functionally to ensure compliance.
Represent regulatory on study teams and maintain knowledge of US and international regulations.
Erasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for cancer patients. The company targets the RAS/MAPK pathway and fosters a collaborative, mission-driven culture.
Lead CMC regulatory strategy for small molecule drugs in global Phase 1-3 trials.
Write and manage investigational regulatory submissions for US, EU, and ROW.
Support risk mitigation and GMP compliance across development programs.
Recursion is a clinical-stage TechBio company decoding biology to radically improve lives. The company employs a global team and fosters a culture of bold action, care, and collaboration.
Lead all operational and lifecycle management aspects of Regulatory CMC submissions supporting cell therapy development programs.
Develop and execute global regulatory CMC strategies aligned with program objectives and regulatory requirements.
Serve as Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development.
BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases. We are a small, mission-driven company with a rapidly growing, dynamic environment.
Lead project initiation, planning, and execution for API and drug product development projects.
Serve as liaison between clients, technical teams, and business development to ensure project success.
Monitor project progress, report to stakeholders, and implement corrective measures using risk assessment tools.
WuXi, through its STA division, provides API and drug product development and manufacturing services. The company is a leading global contract research and manufacturing organization with a focus on small molecule development.
Provide strategic leadership and functional representation for complex projects, ensuring effective coordination and execution of regulatory tasks.
Act as a franchise liaison between Ergomed Plc and clients, assisting in securing new business by participating in bid defenses and contributing to proposals and budgets.
Offer expert regulatory guidance, training, and mentoring to junior staff, while driving department initiatives and managing change implementation.
PrimeVigilance is a global pharmacovigilance specialist that helps clients navigate complex regulations while keeping patient safety at the center of every decision. With a presence across Europe, North America, South America, Asia, and Australia, the company fosters a culture built on kindness, flexibility, growth, and belonging.
Provide QA oversight for CMC drug product and device operations, ensuring compliance with global GMP regulations.
Approve protocols, batch records, and disposition batches for clinical trials in partnership with external vendors.
Support health authority inspections and regulatory filings, driving continuous improvement in sterile manufacturing.
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases through innovative anti-FcRn therapies. As a growing biopharmaceutical firm, the company fosters a dynamic, entrepreneurial culture with a focus on compliance and patient safety.
Lead operational oversight of clinical external manufacturing for drug product, transitioning monoclonal antibodies into scalable processes.
Develop robust aseptic strategies for vial and prefilled syringe formats, managing CMOs and technology transfers.
Collaborate with formulation and device teams to create stable high-concentration liquid formulations and troubleshoot manufacturing issues.
We develop potentially best-in-class therapies for patients with severe autoimmune diseases. Our lead antibody, claseprubart, is engineered for extended half-life and improved potency, and we are building a culture centered on core principles to elevate patient care.
Serve as subject matter expert defining gold standard for regulatory content on an AI platform.
Ensure outputs reflect current agency expectations and are ready for global submission.
Work flexibly 5–20 hours per week in a remote, US-based role.
Edison Scientific builds and commercializes AI agents for science. They are assembling a team of top researchers and engineers across AI and biology with a fast-moving, mission-driven culture.