Senior Regulatory Affairs Specialist Jobs in Indianapolis, IN

Drive regulatory strategy across major programs, leading high-impact submissions and authority engagement. Collaborate with cross-functional teams to optimize clinical development and ensure complianc...

Join a team that's shaping the future of aseptic manufacturing training. Lead initiatives to enhance technical skills and qualifications, collaborating with experts to develop impactful training progr...

Unlock potential by leading regulatory compliance for IVD products, ensuring adherence to global standards. Collaborate with cross-functional teams to assess risks, manage adverse events, and drive co...

Join a global team to shape regulatory strategies in biotechnology, supporting product development and lifecycle management in Inflammation and Rare Diseases. Lead regulatory efforts, ensure complianc...

Unlock potential by leading regulatory writing for complex submissions, mentoring junior writers, and driving departmental initiatives. Collaborate with cross-functional teams to ensure compliance and...

Engage in complex large-molecule bioanalytical method development, leading scientific studies and collaborating with clients to deliver innovative solutions that support drug development programs...

Join a team that's driving innovation in R&D and Regulatory processes. Leverage your Veeva RIM expertise, manage global compliance systems, and implement solutions that meet dynamic business needs whi...

Optimize the release management of finished goods, ensuring compliance with food safety and regulatory standards while leading a team to address non-conformance and enhance quality assurance processes...

Advance your career by leading clinical research projects and ensuring compliance with timelines and standards. Collaborate with stakeholders and clinical sites to safeguard subjects' rights and data...

Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...

Champion regulatory excellence by leading CMC strategies for small molecule programs, ensuring compliance and driving successful submissions from early development through commercialization in a dynam...

Transform regulatory compliance and pharmacy operations by overseeing licensing, accreditation, and audits. Collaborate with clinical leaders to develop scalable practices while ensuring adherence to...

Lead regulatory operations by overseeing submissions, enhancing processes, and mentoring the team. Ensure compliance and accuracy while managing multiple priorities in a dynamic, remote environment. D...

Join a team that's shaping global regulatory strategy for rare disease therapies. In this pivotal role, you'll lead submissions and agency interactions across the US, EU, UK, and Japan, driving execut...

Lead compliance excellence by conducting quality reviews, enhancing processes, and providing expert guidance to ensure timely, accurate client service and adherence to regulatory standards in a dynami...

Drive enterprise Quality and Regulatory governance for U.S. operations, ensuring compliance with FDA regulations and overseeing manufacturing quality in the therapeutic radiopharmaceutical sector whil...

Champion the U.S. Biologics Regulatory CMC team by providing strategic leadership, ensuring timely regulatory submissions, and fostering collaboration among global stakeholders to drive innovative bio...

Help us develop and execute global regulatory CMC strategies for clinical trials and market approvals by leveraging technical knowledge and fostering teamwork across research, manufacturing, and regul...

Drive innovation and transform lives by leading regulatory strategies and submissions for clinical trials globally. Act as a key liaison for project teams to ensure compliance, operational excellence...

Elevate your career by leading global CMC regulatory strategies for biologics. Collaborate with cross-functional teams, ensure compliance, and drive successful product development while mentoring a hi...

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Elevate your career by leading CMC Regulatory strategy and execution. Drive submissions, build a high-performing team, and engage with global health authorities to ensure compliance and success in dru...

Partner with us to innovate and transform Quality & Regulatory operations through technology and data analytics. Drive automation, improve efficiency, and foster effective digital solutions that enhan...

Unlock potential by leading regulatory strategies for innovative medical devices. Collaborate with teams to ensure compliance, execute FDA submissions, manage project timelines, and establish processe...

Drive global regulatory strategy and empower teams to ensure timely product registrations, enhancing access to innovative diagnostic solutions. Collaborate with leadership to shape impactful strategie...