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 regulatory leadership for cell therapy portfolio including commercial readiness and labeling.
Lead global health authority interactions including FDA, EMA, and negotiations for labeling and approvals.
Oversee submissions, mentor a high-performing team, and align regulatory strategy with business objectives.
Kyverna is a biotechnology company developing autoimmune cell therapies. As a late-stage organization, it fosters a collaborative culture in a fast-paced, high-growth environment.
Coordinate and track international regulatory submissions for IVD products in the EMEA region.
Manage regulatory release of products using the GTS tool and ensure compliance with IVD/medical device regulations.
Collaborate with global teams to document regulatory assessments and oversee channel partner licenses and renewals.
Agilent provides life science, diagnostic and applied market laboratories with instruments, services, consumables, applications and expertise. With 18,000 employees worldwide, the company fosters a culture of trust, respect, integrity, and inclusivity.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for clinical trials.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates and regulatory guidance.
Manage study activation processes and act as liaison between sponsors, investigators, and internal departments.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. Winship Cancer Institute is Georgia's only NCI-designated Comprehensive Cancer Center, dedicated to discovering cures for cancer and providing innovative therapies.
Provide regulatory advice and ensure compliance with U.S. regulations and ICH GCP guidelines for clinical research sites.
Coordinate IRB submissions, maintain regulatory documentation, and support site start-up and close-out activities.
Collaborate with cross-functional teams and monitor regulatory changes to advise stakeholders.
Care Access is working to make the future of health better for all by bringing world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA) and facility registration.
Coordinate complaint investigations, risk assessments, and field action notifications while ensuring compliance with ISO 13485 and MDR.
Collaborate with cross-functional teams to prepare documentation, support QMS audits, and maintain regulatory records.
Fujifilm Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging, enterprise imaging, and endoscopic/surgical imaging. With over 70,000 employees globally, the company operates in a dynamic, flexible environment that fuels creativity and collaboration.
Leads writing and preparing clinical and regulatory documents for drug and device development.
Coordinates review, approval, and quality control across functions to ensure compliance and timelines.
Develops knowledge of US and international regulations and participates in process improvements.
AbbVie discovers and delivers innovative medicines and solutions addressing serious health issues in immunology, oncology, neuroscience, and aesthetics. They are a large global biopharmaceutical company committed to having a remarkable impact on people's lives.
Lead integrated drug development strategies across preclinical, clinical, regulatory, and commercial dimensions for pharmaceutical and biotech programs.
Provide expert guidance on clinical development plans, target product profiles, study designs, and regulatory submission strategies.
Engage with global regulatory authorities and support portfolio management, licensing, and business development decisions.
Jobgether uses AI-powered matching to connect candidates with hiring companies. They process applications efficiently and share shortlists with employers, supporting a global, inclusive work environment focused on innovation.
Leads global regulatory strategy and compliance for Merge Healthcare’s medical imaging portfolio.
Oversees global product registrations, device licensing, and market authorization activities.
Provides leadership and expert guidance on emerging regulations and standards.
Merative provides data, analytics, and software for health and social care. It is a medium-to-large company with a remote-first culture and values focus, speed, trust, and inspire.
Manage day-to-day regulatory affairs support, including clinical trial applications and compliance with global regulations.
Provide expert guidance to project stakeholders, ensuring timely and high-quality service delivery.
Develop regulatory strategies and tools, staying current with industry best practices and regulatory changes.
Alimentiv provides global regulatory affairs support services for clinical research. The company emphasizes high-quality service delivery, compliance with industry standards, and a collaborative culture.
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.
Drive regulatory strategies for Expanded Access Programs across global markets, ensuring compliance and patient access.
Act as a subject matter expert in communications with pharmaceutical clients, health authorities, and cross-functional teams.
Prepare and submit regulatory dossiers while maintaining up-to-date knowledge of global frameworks.
Jobgether uses AI-powered matching to connect candidates with jobs at partner companies. They are a fast-growing global organization with a dynamic scale-up environment and high autonomy.
Serve as the primary point of contact and partner with investigative sites to ensure high-quality clinical trial conduct.
Conduct site evaluation, training, monitoring, and closure activities in compliance with regulations, GCPs, and SOPs.
Utilize risk-based monitoring and site engagement strategies to improve data integrity, compliance, and study performance.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. A large global biopharmaceutical company, AbbVie fosters a culture of innovation and integrity to transform patients' lives.
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 study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
Provides quality oversight of QC laboratory activities, ensuring compliance with global GxP regulations across multiple indications.
Manages GMP testing at CMOs and contract testing laboratories, including raw data review and exceptions management.
Collaborates with CMC Manufacturing, Quality Assurance, and Regulatory Affairs to align testing timelines with corporate goals.
Immunovant is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. They are a publicly traded, clinical-stage biopharmaceutical company with a dynamic, fast-paced, entrepreneurial culture.
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.
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.
Provide domain expertise to design and build AI tasks that amplify productivity.
Share knowledge about day-in-the-life workflows for regulatory submissions.
Generate or review reference ground-truth artifacts for evaluation.
Edison Scientific builds and deploys AI scientist agents to accelerate science and the development of new medicines. The team is ambitious and run by scientists and engineers from leading institutions across biology, physics, chemistry, and AI.