Regulatory Affairs Specialist Jobs in Durham, NC

Join a dynamic team to provide comprehensive regulatory support across clinical, submission, and post-approval phases for pharmaceutical products, ensuring compliance with global regulations while man...

Champion compliance and innovation by advising cross-functional teams on FDA advertising regulations, driving strategic decisions to mitigate risks while supporting business objectives in healthcare c...

Lead the charge in regulatory strategy for clinical studies, providing expert guidance on complex global compliance. Drive communication with health authorities and ensure timely documentation while c...

Contribute to innovative regulatory strategies for biofertilizers and biocontrol solutions, acting as a global expert that shapes product development and lifecycle management through strong communicat...

Shape the future of regulatory strategy by leading projects that ensure compliance and market access. Drive collaboration across teams while managing processes for development and post-approval phases...

Take ownership of U.S. regulatory submissions, ensuring accuracy and compliance with FDA requirements. Collaborate cross-functionally to coordinate IND, NDA, and BLA filings, executing processes withi...

Transform regional regulatory engagement by leading strategy, fostering relationships, and advocating for efficient electric transmission policies. Collaborate across departments to align regulatory g...

Lead regulatory activities across biologics projects, ensuring compliance and high-quality submissions. Collaborate cross-functionally from development through post-approval, while serving as the regu...

Shape the future of regulatory promotional operations by driving standards and streamlining review processes of promotional materials. Collaborate cross-functionally to ensure compliance and efficacy...

Lead our regulatory operations team in navigating UDI compliance and FDA regulations for medical devices, ensuring accurate registrations and supporting cross-functional initiatives that enhance produ...

Engage in ensuring compliance with quality regulations, overseeing product release processes, and leading audits. Optimize documentation reviews and improve quality practices within the organization w...

Tackle molecular characterization studies and safety reports to support regulatory submissions for GM crops. Collaborate with cross-functional teams and provide expertise in molecular biology, ensurin...

Join a team that's committed to executing quality assurance for drug substance manufacturing, ensuring compliance with cGMP standards while supporting cross-functional collaboration and continuous imp...

Unlock potential by leading IT & Automation validation efforts, ensuring compliance, conducting technical reviews, and authoring quality documentation. Collaborate with cross-functional teams to drive...

Lead the charge in regulatory strategy and operations for product development, guiding cross-functional teams to ensure compliance and engagement with health authorities while fostering team growth an...

Join us in leading regulatory strategy for utility clients, managing multiple complex projects, and delivering high-quality work while coaching a dynamic team. Your expertise will shape innovative sol...

Lead regulatory initiatives and ensure compliance for nuclear projects, leveraging 5+ years of experience in licensing. Collaborate cross-functionally to drive complex projects and deliver effective d...

Accelerate progress at clinical sites by overseeing monitoring activities, ensuring compliance, and fostering relationships to meet study goals while maintaining data integrity and quality standards a...

Transform regulatory practices by leading licensing projects and enhancing compliance frameworks. Collaborate with cross-functional teams to effectively manage commercial nuclear challenges and secure...

Optimize quality assurance processes by ensuring timely review and approval of deviations and CAPAs. Collaborate with cross-functional teams to mentor staff, improve systems, and provide crucial metri...

Champion regulatory excellence by leading global strategies for product approvals, collaborating with cross-functional teams and external experts to ensure compliance and drive successful commercializ...

Elevate your career by joining us in enhancing quality systems that drive compliance and operational excellence. Collaborate with global teams to maintain and improve QMS processes, ensuring effective...

Lead the charge in ensuring compliance and data integrity for clinical studies through effective site monitoring and management. Collaborate with sites and teams to enhance recruitment, quality assura...

Lead the charge in overseeing Deviation and CAPA processes, ensuring compliance in GMP manufacturing. Collaborate cross-functionally, mentor junior staff, and enhance systems for consistent operationa...

Execute major deviation investigations in biologics manufacturing, ensuring compliance and effective communication between cross-functional teams to enhance processes and drive improvement while manag...