Regulatory Affairs Specialist Jobs in Indianapolis, IN

Empower clinical trial success by leading CAR-T and gene therapy projects. Manage timelines and stakeholder communication while ensuring operational excellence and compliance in a remote, sponsor-dedi...

Champion critical oversight in Sterility Assurance to enhance Biotech manufacturing compliance with GMP and regulatory standards, driving contamination control and aseptic processes across functions f...

Join a team that drives customer success through impactful scientific training, workflow optimization, and expert engagement. This role enhances product adoption and ensures customers achieve valuable...

Advance pharmacovigilance operations by leading daily activities, vendor oversight, and ensuring compliance with regulatory standards, while safeguarding data integrity across clinical development and...

Engage as a crucial support to onsite construction, ensuring environmental compliance, permits, and regulations are met. Collaborate with project teams, monitor activities, and maintain documentation...

Unlock potential by leading quality compliance initiatives, enhancing processes, and ensuring adherence to global medical device regulations. Collaborate with diverse teams to drive best practices and...

Engage customers as a reimbursement expert, delivering education and support while resolving patient access challenges. Collaborate with cross-functional teams to enhance procedural efficiency and ens...

Help us optimize our supply chain processes and drive efficiency by managing partner invoicing, translating demand into production needs, and improving operational workflows in a fast-paced, evolving...

Shape the future of pharmaceutical innovation by providing expert legal counsel, driving patent strategy, and collaborating with R&D teams to navigate complex intellectual property challenges in a dyn...

Elevate your career as a Senior Import/Export Specialist driving compliant and efficient global trade operations. Lead analytics, process design, and cross-functional initiatives, ensuring compliance...

Lead a team to enhance compliance assurance in risk-based oversight. Drive operational excellence by evaluating Regional Entities’ adherence to standards, improving policies, and fostering industry en...

Oversee and execute supplier audits to ensure compliance with cGMP/GxP regulations. Play a key role in evaluating supplier performance, implementing CAPAs, and supporting regulatory inspections for ef...

Manage and enhance clinical trial operations by leading teams and ensuring compliance. Your role involves strategic planning, collaboration, and problem-solving to deliver exceptional trial outcomes w...

Lead the charge in developing compelling proposals for U.S. Government solicitations, ensuring compliance and quality across all phases. Collaborate with cross-functional teams to strategize and execu...

Innovate with us by shaping and operationalizing governance for agentic AI technologies. Collaborate with diverse teams to ensure responsible, compliant AI use at scale while advancing innovative solu...

Drive compliance strategy by managing IL4/IL5 offerings, ensuring regulatory adherence across AWS-hosted environments. Collaborate with security teams, federal regulators, and technical stakeholders t...

Lead model-informed drug development strategies while driving cross-functional collaboration, mentoring scientists, and enhancing regulatory compliance activities within a dynamic and innovative team...

Join a team that's focused on driving systems engineering excellence by defining stakeholder needs, crafting innovative solutions, and ensuring compliance with industry standards. Your role will span...

Shape operational success by managing workflows, documentation, and support for departmental initiatives. Engage in process improvement and collaboration to enhance execution and drive effectiveness i...

Lead the charge in early clinical development, guiding studies from inception to proof-of-concept through collaboration and strategy execution within a dynamic team setting...

Drive new business pursuits in the pharmaceutical services sector, fostering strategic partnerships and achieving growth objectives through proactive development and client engagement...

Lead the charge in designing and supporting critical systems, ensuring reliability and compliance while mentoring junior engineers. Your expertise will drive efficient infrastructure solutions with a...

Champion clinical trial execution by managing timelines, risks, and stakeholder engagement across global teams. Leverage therapeutic expertise to enhance patient value and ensure compliance, driving t...

Deliver exceptional communication strategies for biotech customers while supporting diverse high-impact projects. Collaborate with teams to advance oncology initiatives and ensure timely, high-quality...

Optimize quality assurance processes to ensure compliance with regulatory standards and drive improvements across all operations. Lead a talented team to establish and maintain an effective Quality Ma...