Regulatory Affairs Specialist Jobs in Shepherdsville, KY

Unlock potential by leading site monitoring for clinical trials. Collaborate closely with cross-functional teams to ensure compliance, enhance recruitment, and oversee execution while providing guidan...

Champion regulatory excellence by guiding project teams, developing global strategies, managing submissions, and ensuring compliance with FDA and international regulations while navigating complex env...

Innovate robust global regulatory frameworks to enhance compliance, drive quality initiatives, and support strategic goals across diverse teams while ensuring adherence to international standards and...

Contribute to regulatory excellence by coordinating U.S. submissions, ensuring compliance with FDA standards, and maintaining vital documentation for the Obesity Therapeutic Area, while collaborating...

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...

Shape the future of regulatory strategy by leading cross-functional teams, driving innovative development strategies, and providing regulatory thought leadership to ensure compliance and accelerate pr...

Join as a Clinical Research Associate to oversee critical monitoring tasks across diverse clinical studies. Ensure high-quality standards while facilitating communication between project teams and sit...

Join a team that's dedicated to regulatory compliance and product stewardship, leading efforts across markets in North America. Oversee daily operations, drive continuous improvement, and cultivate a...

Empower healthcare data integration by executing interface projects and collaborating with teams to ensure successful deployments. This role offers a great opportunity for detail-oriented individuals...

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...

Transform healthcare data integration by managing complex projects with minimal guidance. Collaborate with cross-functional teams to solve client issues, optimize data flows, and ensure successful go...

Join a strategic leadership role that executes regulatory strategies globally, overseeing complex submissions and driving cross-functional collaboration to ensure successful market access and complian...

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...

Lead regulatory support for Neurology and Oncology agents, driving strategies and submissions for global approvals. Collaborate across teams to enhance development timelines and ensure compliance with...

Drive operational excellence by managing regulatory affairs processes and supporting scalable promotional material reviews. Collaborate cross-functionally to enhance compliance, training, and automati...

Lead end-to-end GCP audits globally, ensuring compliance and driving improvements in clinical studies. Collaborate with stakeholders to interpret regulations and support regulatory inspections in a dy...

Champion compliance initiatives by conducting research, analyzing trends, and collaborating with teams to ensure accurate and effective regulatory responses. Leverage data-driven insights to support c...

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...

Transform the biopharmaceutical landscape by advising clients on regulatory compliance and clinical pharmacology strategies, leveraging your expertise to impact innovative drug development across dive...

Champion compliance and operational excellence in controlled substances governance, ensuring adherence to DEA regulations while leading strategic initiatives for inventory management, security, and st...

Shape the future of regulatory compliance by leading controlled substance operations, ensuring adherence to DEA regulations, and driving security initiatives in a dynamic 3PL environment. Collaborate...

Manage regulatory submissions and compliance for medical devices. Collaborate across departments to ensure adherence to standards, support audits, and maintain quality throughout clinical processes an...

Lead the charge in compliance strategy for U.S. Commercial and Market Access. Collaborate with senior leaders to guide complex compliance issues, manage risks, and support innovative business objectiv...

Elevate clinical outcomes by serving as the key pharmacist liaison among partners, translating real-world issues into actionable insights, driving resolution of clinical concerns, and enhancing produc...

Join a team that's shaping healthcare through innovative legal counsel. You'll oversee commercial contracting, guide compliance, and streamline legal operations for critical partnerships in health sys...