Regulatory Affairs Manager Jobs in Lincoln, NE

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...

Advance patient safety operations by managing a team, ensuring compliance, and enhancing pharmacovigilance processes while fostering a collaborative environment for continuous improvement and innovati...

Take ownership of a critical pipeline initiative, driving qualified study opportunities via strategic account-based marketing and cross-functional collaboration, focused on delivering real-world evide...

Join our team as a Project Manager to oversee clinical studies, ensuring adherence to protocols, timelines, and regulations. Collaborate with clinical teams and sponsors to drive project success and d...

Unlock potential by shaping global regulatory strategies and driving advocacy initiatives. Collaborate across teams to manage regulatory risks, assess opportunities, and provide strategic insights tha...

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

Join a team that's dedicated to advancing regulatory strategies for innovative SaMD products. Collaborate cross-functionally to drive compliance, manage documentation, and ensure readiness for audits...

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...

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...

Contribute to lead risk-based quality management for oncology trials across phases. Collaborate with cross-functional teams to assess risk, ensure data quality, and drive mitigation. Provide expert gu...

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...

Elevate your career by leading compliance and quality in clinical trials. Collaborate with teams to ensure protocol adherence, site training, and resolve issues while maintaining high standards of mon...

Tackle clinical monitoring challenges while leading site initiatives for quality compliance and protocol adherence. Collaborate with cross-functional teams to ensure successful clinical trial executio...

Optimize your clinical research career by playing a vital role in overseeing and conducting site monitoring for clinical trials, ensuring compliance, quality, and effective team collaboration througho...

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...

Drive reimbursement strategies to enhance access for healthcare providers. Collaborate across teams to support product initiatives, build relationships, and navigate payer landscapes, ensuring effecti...

Transform quality technology strategy by aligning teams, enhancing processes, and driving innovation in regulated environments. Lead the charge to optimize quality management systems while fostering a...

Lead global strategy for Notified Body engagement, ensuring compliance, managing audits, and driving certification readiness across various jurisdictions. Guide integration assessments, enhance proces...

Manage and drive sales success in genomics services, cultivating client relationships while achieving revenue targets. Collaborate with cross-functional teams to develop innovative solutions tailored...

Lead middle revenue cycle improvements by managing client medical coding operations, ensuring quality compliance, and optimizing team performance. Drive strategic initiatives while fostering a collabo...

Support the identification and evaluation of safety data, facilitating signal detection and compliance with regulations while effectively communicating safety assessments to stakeholders. Lead safety...

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...

Redefine quality excellence by leading ISO 9001 certification efforts and fostering a culture of continuous improvement across engineering, safety, and operations, ensuring safe, reliable products in...

Elevate the Promotional Review Committee's effectiveness by leading the compliant review process of promotional materials. Drive cross-functional collaboration, enhance operational workflows, and ensu...