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.
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.
Manage complex regulatory activities related to active pharmaceutical ingredients, including DIFA/DMF processes and lifecycle management.
Provide strategic guidance and risk management support for API documentation and supplier qualification.
Collaborate with multidisciplinary teams and external partners to ensure regulatory compliance and operational excellence.
The partner company is a player in the pharmaceutical industry, focusing on regulatory affairs and lifecycle management of innovative products. The team size and culture are not specified, but the role emphasizes collaboration, continuous improvement, and remote work based in Brazil.
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.
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.
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.
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.
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.
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.