Regulatory Affairs Specialist Jobs in Indianapolis, IN

Join a team that's driving quality compliance in clinical development. As a strategic leader, you'll oversee QMS effectiveness, risk management, and compliance initiatives, while partnering with stake...

Unlock potential by providing legal guidance for BaaS and payments initiatives, collaborating across teams to translate banking regulations into practical solutions, and ensuring compliance while fost...

Shape the future of medical devices by leading regulatory CMC strategies, ensuring compliance and collaboration across teams to drive the development of innovative combination products for patients wo...

Take ownership of regulatory project management, leading submissions and cross-functional communication to drive timely, high-quality regulatory actions in clinical programs. Collaborate closely with...

Empower innovation in quality compliance by overseeing GCP activities, conducting audits, managing regulatory inspections, and ensuring effective risk mitigation strategies throughout clinical develop...

Lead regulatory teams to shape global registration strategies and ensure compliance. Drive innovative approaches, influence cross-functional initiatives, and support business growth through proactive...

Shape the future of medical information by serving as a key expert in a dynamic role that combines your scientific expertise with technology and content development to ensure high-quality responses fo...

Drive compliance excellence as a strategic partner, shaping governance and mitigating risks in global healthcare. Oversee a comprehensive compliance program while collaborating with cross-functional t...

Support validation activities in GMP environments by managing commissioning, qualification, and validation strategies. Partner cross-functionally to ensure compliance and maintain the validated state...

Empower regulatory compliance within the 340B Program by interpreting complex regulations, advising internal teams, and ensuring operational readiness. Drive impactful educational initiatives and coll...

Manage comprehensive risk-based quality audits across multiple sites, ensuring compliance with GCP standards. Collaborate globally with cross-functional teams to enhance clinical study integrity and c...

Unlock potential by supporting project compliance tracking and permitting functions. Collaborate with agencies to ensure adherence to regulations while managing documentation and communication for con...

Unlock potential as you drive US market access strategy, ensuring effective payer and provider engagement while leading reimbursement initiatives and enhancing patient access outcomes across the healt...

Take ownership of operational excellence in clinical trials by overseeing processes, guiding teams, and implementing improvements to ensure effective, compliant, and timely execution of research proto...

Innovate global CMC regulatory strategies and submissions for biological products. Ensure high-quality compliance with US and Canadian regulations, while collaborating cross-functionally to manage lif...

Transform government pricing strategies by managing client relations and ensuring accurate federal drug price calculations while mentoring a team of analysts and providing expert guidance in complianc...

Join a dynamic team as you drive sales success by providing expert technical guidance on cell and gene therapy applications, enhancing product innovation while ensuring clients receive tailored soluti...

Empower compliance excellence by leading audit programs, enhancing trade systems, and driving regulatory improvements. Collaborate with teams to optimize import/export processes and mitigate risks whi...

Transform trade compliance processes and ensure regulatory adherence while leading projects that enhance operational efficiency and promote awareness across the organization. Engage with partners to d...

Unlock your potential as a key leader in GxP auditing, driving compliance and quality oversight across computerized systems in regulated environments. Collaborate cross-functionally to enhance risk ma...

Join a team that's dedicated to ensuring dietary supplement quality by executing robust QA GMP compliance processes. Your expertise will be pivotal in managing supplier quality and driving continuous...

Unlock potential by driving technical sales in the gene therapy sphere, managing demos, and accelerating product adoption. Collaborate with Central Sales to convert opportunities and support long-term...

Transform the contract lifecycle process by drafting, negotiating, and administering agreements. Collaborate with stakeholders to ensure compliance and clarity in all contractual engagements, while su...

Champion the validation of cutting-edge lab instrumentation while collaborating with diverse teams to ensure customer readiness and operational excellence. Your expertise will drive quality and compli...

Join a dynamic team to develop and optimize business rule logic, ensuring alignment with operational goals. Collaborate with multiple departments to identify and resolve technical limitations, fosteri...