Regulatory Affairs Specialist Jobs in Durham, NC

Shape the future of reimbursement project assessments by leading technical reviews, guiding analysts, and establishing impactful frameworks, standards, and processes. Collaborate cross-functionally to...

Lead the charge in enhancing supplier quality management across multiple sites. Ensure compliance with regulatory standards, drive continuous improvement initiatives, and serve as the key liaison for...

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...

Elevate our global labeling strategy by leading end-to-end processes, driving compliance, and optimizing product positioning through precise, defensible labeling language while collaborating across te...

Deliver exceptional support and expertise in operational processes, driving solutions to complex issues while mentoring peers and ensuring compliance with business and regulatory standards...

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...

Transform regulatory affairs in oncology by leading strategic submission initiatives and cross-functional collaborations, ensuring compliance and quality for impactful development programs. Drive regu...

Champion recall operations by managing teams, executing FDA-compliant strategies, and driving cross-functional alignment to ensure timely product corrections and removals while maintaining regulatory...

Contribute to quality assurance by overseeing GCP activities, managing audits, and ensuring compliance. Collaborate with stakeholders to assess risks and improve quality processes, maintaining high st...

Join a team that's driving patient access to groundbreaking gene therapy products. Leverage your expertise in health systems and reimbursement to educate stakeholders and facilitate timely product ava...

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...

Shape the future of engineering and maintenance excellence by leading strategic initiatives in validation, reliability, and automation to enhance operational performance and regulatory compliance in p...

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...

Champion growth by driving sales strategies, engaging healthcare professionals, and delivering insightful product knowledge across the territory, ensuring compliance and fostering lasting partnerships...

Support compliance with NERC standards by enhancing operational risk management and guiding audit preparations. Collaborate with teams to maintain policies, monitor compliance efforts, and ensure regu...

Lead the charge in directing a national Community Medical Liaison program, ensuring effective project oversight, strategic partnerships, and high team performance in support of Neuroscience initiative...

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...

Drive process engineering excellence in a dynamic manufacturing environment by providing technical support, optimizing operations, and ensuring compliance with regulatory standards for parenteral drug...

Engage with key stakeholders to develop and lead strategic policy initiatives that drive Travere Therapeutics' mission in rare disease advocacy and legislation. Collaborate cross-functionally to influ...

Join a dynamic team to manage and optimize clinical supply chain operations. Collaborate cross-functionally to ensure efficient drug supply for trials, while identifying risks and driving process impr...

Join us in leading clinical trial projects across multiple regions, ensuring quality and compliance while mentoring teams and collaborating with stakeholders. Your expertise will help drive success in...

Unlock a pivotal role in manufacturing sciences, enhancing single-use materials through expert analysis and collaboration, driving compliance and innovation in biopharmaceutical production processes...

Innovate with us to enhance our Third Party Risk Management program through automation and collaboration. Join a dynamic team that transforms security governance into an engineering discipline, elevat...

Empower growth through technical sales in gene therapy, driving new business and enhancing customer experiences. Collaborate with Central Sales to manage accounts and leverage technical insights for l...