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.
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 strategic leadership and oversight for all clinical data management activities across the development program.
Partner with cross-functional leaders to ensure data integrity and support timely, high-quality decision making.
Oversee vendor management, data governance, and delivery of inspection-ready clinical data.
Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases like MASH. They are a team of problem solvers with a collaborative culture, dedicated to bringing out the best in each other.
Manage provider and clinic compliance relationships, including onboarding and edge case resolution for approximately 3,500 clinics.
Lead investigations into prescribing pattern anomalies and credential lapses, producing written summaries and communicating outcomes.
Build and deliver compliance training for the sales team and develop provider-facing educational materials.
Strive Pharmacy is a personalized compounding pharmacy focused on individualized care and genuine partnership with patients and providers. The company is growing and seeks people who share their conviction for a more human approach to healthcare.
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.
Develop global clinical strategies to support clinical evidence requirements for product submissions.
Ensure adequate monitoring is conducted on all clinical trials and work directly with regulatory bodies for approvals.
Select, interface with, and assure training of investigators, physicians, and clinical staff.
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance patients' lives, and supplies high-end niche batteries for specialized markets. We are guided by six Values: Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity, fostering a culture of passionate excellence within our team of over 10,000 employees.
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.
Develop safety management plans and oversee serious adverse event case management from intake to regulatory reporting.
Perform intake, triage, data entry, medical coding, and narrative composition for individual case safety reports.
Provide safety training, review standard operating procedures, and assist clients with safety-related reviews.
Precision Medicine Group is a global contract research organization specializing in clinical research and drug development services. The company fosters a collaborative culture and offers competitive benefits to support employee growth.