Regulatory Affairs Manager Jobs in Durham, NC

Drive regulatory strategy by collaborating cross-functionally to influence promotional activities, ensuring compliance while optimizing risk management for impactful business decisions across a dedica...

Drive global regulatory labeling initiatives, ensuring compliance and quality of documentation across diverse markets. Lead strategic governance, influence policies, and collaborate cross-functionally...

Lead global regulatory strategies for oncology programs, ensuring compliance and effectively interacting with regulatory agencies for product approvals in late-stage development...

Drive your career by leading regulatory and scientific initiatives that ensure product compliance while supporting strategic business goals, managing complex projects, and engaging stakeholders across...

Unlock potential by driving regulatory submissions and managing documentation. Collaborate with global teams to align on strategies, ensuring compliance and effective communication while fostering a c...

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...

Provide regulatory expertise by preparing submissions, ensuring compliance, and collaborating with teams to maintain quality guidelines, supporting product development efforts and compliance with glob...

Empower clinical research success by managing regulatory and start-up activities for multiple projects. Lead IRB submissions, essential documents, and Trial Master Files, ensuring compliance and audit...

Join a team dedicated to ensuring drug quality compliance by performing data integrity audits, assessing adherence to FDA standards, and providing actionable recommendations to enhance regulatory deci...

Join our team to lead regulatory strategies across major programs, driving impactful submissions and fostering collaboration within a challenging and dynamic environment. Embrace the opportunity to in...

Elevate operational excellence by leading strategic compliance initiatives and driving process improvements across production teams to meet quality standards and business needs...

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

Collaborate with clients and teams to manage projects, expectations, and delivery, ensuring high standards and strategic growth in a fast-paced medical affairs environment. Leverage experience to iden...

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...

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...

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...

Lead the charge in developing global regulatory strategies for clinical programs. Manage regulatory operations for product lifecycle while collaborating with cross-functional teams to ensure successfu...

Join a pivotal role in regulatory affairs, guiding promotional materials in compliance with FDA and provincial guidelines in a dynamic, remote environment. Lead the Materials Review Committee and shap...

Lead the charge in global regulatory strategies for innovative medical devices, driving project success from registration to compliance. Collaborate across teams to enhance healthcare technologies and...

Engage with a dynamic team to facilitate regulatory operations for novel therapeutics. Drive submissions to FDA/CVM while collaborating across multidisciplinary teams to set new regulatory standards i...

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...

Shape the future of quality assurance by leading site operations, ensuring regulatory compliance, and driving improvements in pharmaceutical distribution and manufacturing processes while safeguarding...

Elevate your career by leading an engineering team to optimize performance in a high-quality manufacturing setting. Drive improvement initiatives, ensure compliance, and develop talent to meet strateg...

Grow your career with us as you lead validation activities to ensure compliance and support continuous improvement in a high-paced pharmaceutical environment. Collaborate across teams and drive strate...

Lead the charge in enhancing quality assurance programs by steering a talented team. Drive AI integration and continuous improvement to ensure accuracy, reduce risks, and optimize client outcomes thro...