Regulatory Affairs Specialist Jobs in Raleigh, 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...

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...

Champion regulatory compliance by supporting quality processes and product lifecycle management in the medical device sector, ensuring adherence to standards during design, development, and commercial...

Reimagine Regulatory Affairs by leading complex outsourcing programs and driving client success. Utilize deep expertise in strategy and operations to manage projects, mentor teams, and deliver tailore...

Optimize regulatory compliance initiatives within healthcare departments, ensuring adherence to CMS and DOH regulations. Collaborate effectively with multiple teams to assess risks, develop action pla...

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...

Champion regulatory excellence by guiding cross-functional teams in FDA advertising compliance while mitigating risks and enhancing strategic communications to support business goals...

Join a dynamic team and lead regulatory strategies for in vitro diagnostics, ensuring compliance and successful submissions while collaborating cross-functionally. Manage project timelines and mentor...

Lead and manage the supplier quality program to ensure compliance with regulatory standards, execute supplier evaluations, and support audits for a seamless quality management system in a dynamic envi...

Elevate product registration processes by leading global regulatory strategies, preparing detailed dossiers, and ensuring compliance with labeling requirements across diverse markets to facilitate pro...

Accelerate progress at the forefront of pharmaceutical development by leading regulatory strategies. Collaborate cross-functionally to ensure timely submissions and compliance with FDA standards, driv...

Lead the charge in ensuring regulatory compliance globally for Expanded Access Programs, enhancing patient access to innovative therapies through collaboration across diverse teams while maintaining q...

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...

Elevate your career by leading Quality Risk Management and Data Integrity initiatives, ensuring compliance and operational excellence in a dynamic environment, while fostering a robust quality culture...

Lead strategic execution for global Risk Management initiatives, managing projects and delivering high-quality documentation across cross-functional teams while ensuring compliance with regulatory sta...

Accelerate your impact by winning high-value, complex opportunities through innovative workflow design and technical expertise, while shaping market direction and influencing strategic commercial deci...

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...

Engage in vital clinical monitoring activities, ensuring compliance and quality across multiple studies. Collaborate with teams, maintain site relations, and support timely project milestones to enhan...

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

Develop and optimize reliability strategies for electrical and mechanical systems. Lead root cause analysis and ensure proactive maintenance, leveraging technical expertise to enhance asset health and...

Join us to support analytical method validation and technology transfer, ensuring compliance and product quality. Collaborate across teams to drive regulatory success for small molecules and ASO produ...

Advance our quality assurance efforts by driving compliance and enhancing processes. You'll lead audits, document reviews, and mentor team members, ensuring high GMP standards and instilling a culture...