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 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.
Provide strategic scientific leadership for clinical pharmacology across all development phases from Phase 1 through Phase 3.
Design and oversee clinical pharmacology studies, including PK/PD, exposure-response, and modeling and simulation activities.
Collaborate with cross-functional teams and support regulatory submissions to global health authorities.
Amylyx is a clinical-stage biotechnology company focused on developing therapies for diseases with high unmet needs, including ALS, Wolfram syndrome, and post-bariatric hypoglycemia. The company fosters a culture of caring with core values of audacity, curiosity, authenticity, engagement, and accountability, and has assembled an experienced team ready to tackle tough medical problems.
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.
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 CMC strategy and execution across clinical-stage therapeutic programs, ensuring regulatory alignment and manufacturing readiness.
Oversee external partnerships with CDMOs, consultants, and regulatory experts to deliver high-quality programs.
Manage CMC activities from due diligence through clinical development, balancing scientific rigor with operational speed.
The company is a partner organization in the biopharmaceutical industry, focusing on clinical-stage therapeutic programs. It operates in a high-growth, mission-driven environment with a culture of innovation and collaboration.
Lead the study start-up process, developing strategy and coordinating regulatory deliverables to meet targets.
Serve as primary contact for start-up activities, prepare and review regulatory documents, and ensure compliance with ICH-GCP and regulations.
Manage essential document collection, site correspondence, contract negotiations, and support team training and budget monitoring.
Ergomed is a mid-sized contract research organization specializing in oncology and rare disease. The company has a global presence with operations in Europe, North America, and Asia, and emphasizes employee well-being, work-life balance, and career development.
Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.
Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.
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.
We accelerate breakthrough science and delivery of life-enhancing therapies through our expertise, insight, consulting and management skills. We were recently honored with BioSpace's 'Best Places to Work' 2026 award, fostering a positive and engaging work environment with emphasis on culture, career growth, and development.
Provide scientific and strategic DMPK guidance across a biologics portfolio, supporting monoclonal antibodies, bispecifics, and targeted-delivery platforms.
Design and lead PK, bioanalysis, and immunogenicity studies to optimize candidate selection and progression.
Collaborate with cross-functional teams and external partners to ensure regulatory readiness and support IND filings.
Pioneering Medicines is the in-house drug development unit of Flagship Pioneering, focused on creating novel treatments from Flagship's scientific platforms. It is part of a larger organization known for innovation, with a collaborative and fast-paced culture.
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.
Responsible for submission planning and management of IND-related activities, including annual reports, DSURs, and CTA activities.
Manages the compilation, QC, and submission of INDs, BLAs, and amendments, and prepares routine regulatory documents.
Represents Regulatory Affairs on cross-functional teams, providing expertise and managing submission trackers.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.
Independently manage all operational aspects of Phase I clinical trials from startup through closeout, ensuring adherence to protocols and regulations.
Oversee CROs and vendors to ensure alignment with study goals, budget, and timelines.
Lead the company-wide rollout of Veeva Vault, serving as a primary operational user and subject matter resource.
Absci is a clinical-stage biotechnology company leveraging generative AI for drug discovery through its Integrated Drug Creation platform. The company has a global presence with offices in the US, Switzerland, and Serbia, and fosters a collaborative, innovative culture.
Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stages from early development through approval, with embedded experience in oncology and rare disease.
Own CMC oversight across every active asset, ensuring on-time and on-budget delivery of drug substance, drug product, analytics, stability, and regulatory filings.
Select, contract, and manage CDMOs and external partners, holding them to timelines, quality, and cost.
Scope and de-risk the CMC of inherited in-licensing candidates, flagging manufacturing complexity or cost that could affect asset viability.
Our mission is to fix the broken clinical-stage biopharma model by in-licensing therapeutic assets and developing them through integrated, technology-first clinical trial infrastructure. We are a new initiative built on a proven foundation, with a team that has delivered 40+ trials across the US and Europe, and we are a high-growth, mission-driven, VC-funded startup.
Create and execute clinical operational strategic plans aligned with product strategy and resource allocation.
Build, develop, and train internal staff and external vendors to enhance efficiency and engagement.
Oversee relationships with Contract Research Organizations, vendors, and investigative sites to ensure compliance with FDA and ICH GCP guidelines.
Lycia Therapeutics is a biotechnology company using its proprietary LYTAC platform to develop therapeutics that degrade extracellular and membrane-bound proteins. Founded in 2019, the company has raised $75 million in Series D financing and is headquartered in South San Francisco.
Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production with a focus on quality and compliance.
Provide oversight of CROs, vendors, and internal teams, recruiting and leading CDM staff to meet clinical trial timelines and budgets.
Partner cross-functionally on data management issues, identify risks, and propose solutions to ensure inspection-ready, high-quality data.
Definium Therapeutics is a late-stage clinical biopharmaceutical company applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders. Headquartered in New York and traded on Nasdaq (DFTX), the company is advancing a new generation of therapeutics with a focus on turning evidence into impact.
Responsible for preparing and submitting clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manages site start-up activities including essential document collection, informed consent form review, and coordination with investigators and contracts.
Acts as a subject matter expert for regulatory submissions and may support process improvement, training, and mentoring.
Precision for Medicine is a clinical research organization (CRO) that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed and success rate of bringing therapies to patients, with a focus on Oncology and Rare Disease. It is a growing company with a culture of innovation and collaboration.
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.
Play a critical role in supporting clinical development programs across the Dianthus portfolio, driving data quality and operational excellence.
Oversee all clinical data management activities and deliverables from study start-up through database lock and closeout across multiple clinical trials.
Ensure the delivery of complete, accurate, high-quality, and regulatory-compliant data to support study reporting, publications, and regulatory submissions.
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives.